510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K845002Substantially Equivalent

Cuddle Heart -Auditory/vibration Device

International Purchasing Services, Newbury Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K845002 is the FDA 510(k) clearance record for CUDDLE HEART -AUDITORY/VIBRATION DEVICE, a class II device, cleared for International Purchasing Services on under FDA product code FMS (Bed, Pediatric Open Hospital). FDA records list 3 510(k) clearances for International Purchasing Services. As of , FDA records show no recalls naming K845002.

Clearance record

Decision date
Received
(483 days to decision)
Product code
FMS Bed, Pediatric Open Hospital
Regulation
21 CFR 880.5140
Device class
Class II
Review panel
General Hospital
Applicant
International Purchasing Services P.O. Box 934, Newbury Park CA
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