510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915779Substantially Equivalent

Affinity Bed Model 3600 Series

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

K915779 is the FDA 510(k) clearance record for AFFINITY BED MODEL 3600 SERIES, a class II device, cleared for Hill-Rom, Inc. on under FDA product code KNC (Table, Obstetric (And Accessories)). FDA records list 38 510(k) clearances for Hill-Rom, Inc., from to . As of , FDA records show 11 recalls naming K915779.

Clearance record

Decision date
Received
(428 days to decision)
Product code
KNC Table, Obstetric (And Accessories)
Regulation
21 CFR 884.4900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hill-Rom, Inc. 1069 E. Rt 46, Batesville IN
510(k) summary
Statement
Third party review
No

Clearances, product code KNC

Trailing 12 months

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

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