510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881019Substantially Equivalent

Babyrocker

Cinventa AB, Sweden, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881019 is the FDA 510(k) clearance record for BABYROCKER, a class II device, cleared for Cinventa AB on under FDA product code FMS (Bed, Pediatric Open Hospital). FDA records list one 510(k) clearance for Cinventa AB. As of , FDA records show no recalls naming K881019.

Clearance record

Decision date
Received
(89 days to decision)
Product code
FMS Bed, Pediatric Open Hospital
Regulation
21 CFR 880.5140
Device class
Class II
Review panel
General Hospital
Applicant
Cinventa AB Utlandagatan 24, Sweden, SE
Third party review
No

Clearances, product code FMS

Trailing 12 months

FDA records hold no clearances under product code FMS in the trailing twelve months.

FDA records show no clearances under product code FMS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260