510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945729Substantially Equivalent

Dynamicaire(tm) Sleep Surface, Zoneair(tm) Sleep Surface

Hill-Rom Inc., Batesville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945729 is the FDA 510(k) clearance record for DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE, a class II device, cleared for Hill-Rom, Inc. on under FDA product code IOQ (Bed, Flotation Therapy, Powered). FDA records list 38 510(k) clearances for Hill-Rom, Inc., from to . As of , FDA records show no recalls naming K945729.

Clearance record

Decision date
Received
(97 days to decision)
Product code
IOQ Bed, Flotation Therapy, Powered
Regulation
21 CFR 890.5170
Device class
Class II
Review panel
Physical Medicine
Applicant
Hill-Rom, Inc. 1069 State Rte. 46 E., Batesville IN
510(k) summary
Summary
Third party review
No

Clearances, product code IOQ

Trailing 12 months

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

FDA records show no clearances under product code IOQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IOQ, 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