510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011693Substantially Equivalent

Trumpf Surgical Lights, Models 301,501,701,1001

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

K011693 is the FDA 510(k) clearance record for TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001, a class II device, cleared for Trumpf Medical Systems, Inc. on under FDA product code FSY (Light, Surgical, Ceiling Mounted). FDA records list 38 510(k) clearances for HILL-ROM, INC., from to . As of , FDA records show 3 recalls naming K011693.

Clearance record

Decision date
Received
(13 days to decision)
Product code
FSY Light, Surgical, Ceiling Mounted
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Trumpf Medical Systems, Inc. 415 Jessen Ln., Charleston SC
510(k) summary
Summary
Third party review
Yes

Clearances, product code FSY

Trailing 12 months

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

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