Chrysalis Intelligence · Sponsors · Happiest Baby, Inc.

Happiest Baby, Inc.

Los Angeles, CA, US · 1 510(k) clearances · 2 recalls

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Total clearances

1

2023-03-30 → 2023-03-30

Last 12 months

0

Product codes

1

Most recent

2023-03-30

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
QTG	Infant Supine Sleep System	Class II	General Hospital	1	2023-03-30

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2026-08-07

Date	Severity	Status	Recall #	Product	Code	Reason
2026-08-07	Class II	Ongoing	Z-3176-2026	Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101…	—	Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
2026-08-07	Class II	Ongoing	Z-3175-2026	Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 …	—	Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2023-03-30	DEN210039	SNOO Smart Sleeper	QTG	Class II	General Hospital