Owlet vs Nanit: FDA Clearance Status, Recalls and What Each Monitor Actually Does
A side-by-side look at the Owlet Dream Sock and Nanit cameras using FDA database records, CPSC recall searches and the makers' own product pages. No prices, no winner.
What parents should know
- Owlet Dream Sock: FDA De Novo DEN220091, Class II, product code QYU, decision date November 8, 2023 (FDA).
- Owlet BabySat is a separate, prescription-only pulse oximeter cleared through 510(k) K222597 on June 16, 2023 (FDA).
- Nanit sells camera-based monitors with sleep tracking; we found no FDA clearance or authorization for them.
- No CPSC recalls were listed for either brand name in our October 24, 2026 search (SaferProducts.gov).
- Safe sleep (back to sleep, firm flat surface, empty crib, room-sharing) matters more than any monitor (AAP).
- We have no commercial relationship with Owlet or Nanit. This comparison is not paid.
Disclosure: how we wrote this comparison
TeachToddler has no commercial relationship with Owlet or Nanit. Neither company paid for, reviewed or approved this article, and comparisons on our site are never sponsored. We did not test these devices. Every spec below comes from the FDA databases, the CPSC recall database or the makers' own pages. Where we could not confirm a detail, the table says "Not listed." We do not list prices because they change often.
Side-by-side: what the records say
| Owlet Dream Sock | Nanit (Pro camera and wearables) | |
|---|---|---|
| Device type | Wearable sock sensor with base station and app | Overhead video camera with app; breathing tracking uses patterned wearables (Nanit) |
| FDA status | De Novo granted, DEN220091 (FDA) | No FDA clearance found |
| Device class | Class II, over the counter | Not a medical device (not listed by FDA) |
| What it measures | Pulse rate and oxygen saturation, with notifications when readings fall outside preset ranges (FDA decision summary) | Video, sound, sleep patterns; breathing motion with Nanit wear (Nanit) |
| Labeled age and weight | 1 to 18 months, 6 to 30 lb (FDA) | Not listed |
| Intended for | Healthy infants; not for infants with medical conditions | General household use |
| CPSC recalls found | None listed | None listed |
Owlet's FDA history, explained
Owlet's original Smart Sock was sold as a wellness product without FDA authorization. In an October 2021 warning letter, the FDA said the Smart Sock family was being marketed without clearance or approval, because products that measure oxygen saturation and pulse rate and alarm when readings leave preset values are medical devices (FDA warning letter). Owlet then suspended U.S. distribution of the Smart Sock. In June 2024 the FDA issued a close-out letter saying Owlet appeared to have addressed the violations (FDA close-out letter). The company then sought authorization through the De Novo pathway, which is used for new, low-to-moderate-risk devices with no existing equivalent.
The FDA granted De Novo DEN220091 for the Owlet Dream Sock on November 8, 2023, creating a new device type under product code QYU (FDA). The decision summary describes it as an over-the-counter device that displays pulse rate and oxygen saturation and sends notifications when readings move outside preset ranges (FDA). It is not labeled to diagnose, treat or prevent any disease, including SIDS.
A separate product, Owlet BabySat, was cleared as a prescription pulse oximeter through 510(k) K222597 on June 16, 2023 (FDA). That one is meant for babies whose doctor wants home oximetry, which is a different use from the consumer Dream Sock.
Nanit: a camera, not a medical monitor
Nanit makes overhead Wi-Fi cameras with an app that shows video, sound and sleep analytics. Its breathing tracking reads motion from patterned "Nanit wear" such as a swaddle or band (Nanit). We found no FDA clearance or De Novo record for a Nanit product, so it should be viewed as a convenience camera, not a medical device.
That doesn't make it unsafe. It means the FDA has not reviewed its accuracy for any medical claim. If your baby has a condition that needs monitoring, ask your pediatrician which device they want you to use.
Recalls: what we searched and found
On October 24, 2026 we queried the CPSC recall database (via SaferProducts.gov) for "Owlet" and "Nanit." Both searches returned no recalls (SaferProducts.gov). A missing recall does not prove a product is perfect, so check the CPSC recalls page and register your device with the maker so you hear about any future notice.
For cameras, the CPSC's main concern across the category is cord strangulation. Mount any camera and its cord at least 3 feet away from the crib, and use the maker's cord covers.
Which fits which family (no winner)
- Want an FDA-authorized reading of pulse and oxygen for a healthy baby, and are comfortable with a wearable? The Owlet Dream Sock is the only one of the two with FDA authorization.
- Want to see and hear your baby and track sleep patterns? A Nanit camera does that; Owlet also sells a camera that can pair with the sock.
- Baby born early or has heart or lung issues? Ask your pediatrician. Prescription monitoring, such as an oximeter your doctor orders, may be the right tool.
- Anxious about false alarms? Ask how to respond to a notification before you start, and remember that no reading replaces safe sleep habits.
When to call the doctor
Frequently asked questions
Is the Owlet Dream Sock FDA approved?
It received FDA De Novo authorization (DEN220091) on November 8, 2023. De Novo is an authorization, often called a grant, rather than a PMA approval.
Is Nanit FDA cleared?
We found no FDA clearance for any Nanit product. Nanit cameras are consumer video monitors.
Have Owlet or Nanit had a recall?
Our CPSC database search on October 24, 2026 found no recalls listed under either name.
Does Owlet prevent SIDS?
No. It is not labeled to prevent SIDS, and the AAP advises against using home monitors as a SIDS-reduction strategy.
What ages is the Owlet Dream Sock for?
Healthy infants 1 to 18 months and 6 to 30 lb, per the FDA record.
Is this comparison sponsored?
No. We have no commercial relationship with Owlet or Nanit, and comparisons on TeachToddler are never paid.
Keep reading
Sources
This guide was checked against the current guidance below. Medical and safety recommendations can change; use the linked source and your child's clinician for decisions specific to your family.
- FDA De Novo database: DEN220091, Owlet Dream Sock
- FDA De Novo decision summary DEN220091 (PDF)
- FDA warning letter to Owlet Baby Care, October 5, 2021
- FDA close-out letter to Owlet Baby Care, June 5, 2024
- FDA 510(k) K222597, Owlet BabySat (PDF)
- CPSC / SaferProducts.gov recall database search
- CPSC recalls
- AAP: Sleep-related infant deaths, 2022 recommendations (Pediatrics)
- HealthyChildren.org (AAP): A parent's guide to safe sleep
- Owlet (manufacturer)
- Nanit (manufacturer)