Atlas FDA

FTA

26 FDA 510(k) clearances · Product code

50 daysmedian time to decision
204 days90th percentile
26clearances measured

FDA profile

Official device name
Light, Surgical, Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 20 · 2022: 14 · 2023: 105 · 2024: 29 · 2025: 19 · 2026: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Universal Light Handle Cover, Light Handle Cover (K150532)Key Surgical, Inc.2015-09-22
Operating Room Light Handle Adapter (K142386)Litex Manufacturing, Inc.2014-09-29
SURGICAL LIGHT HANDLE COVER (K133554)Microtek Medical, Inc. an Ecolab Company2014-04-08
IDSS SLC (K133413)Black Diamond Video2014-01-07
OASYS SURGICAL LIGHT CONTROLLER (K112133)Oasys Healthcare2012-03-01
EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (K102791)Image Stream Medical, Inc.2010-11-23
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (K081698)Image Stream Medical, Inc.2008-07-30
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (K053321)Xodus Medical, Inc.2006-01-19
SCB/STERIS OR-LIGHT INTERFACE BOX (K051505)KARL STORZ Endoscopy-America, Inc.2005-08-11
KSEA SCB ACC CONTROL (K023704)KARL STORZ Endoscopy-America, Inc.2003-01-30
KSEA SCB MEDIA CONTROL (K020640)KARL STORZ Endoscopy-America, Inc.2002-05-28
DISPOSABLE LIGHT HANDLE AND ADAPTOR (K020304)Aspen Surgical Products, Inc.2002-02-14
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER (K993089)Deroyal Cardiovascular, Inc.1999-10-14
MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE (K954940)Mdt Biologic Co.1996-01-17
SATURN LIGHT (K935102)Burton Medical Products Corp.1994-06-27
PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER (K915068)American Medical Mfg., Inc.1992-02-06
MICROTEK'S SURGICAL LAMP HANDLE & COVER (K901154)Microbio-Medics, Inc.1990-03-20
WELCON LIGHT HANDLE (K894397)Welcon, Inc.1989-08-10
TC SYSTEM-HANDLE (K890866)Transmedical Corp.1989-03-14
TC SYSTEM-COVER (K890867)Transmedical Corp.1989-03-14
SURE COUNT LIGHT HANDLE COVER (K890539)Kleen Test Products1989-02-27
LIGHT, SURGICAL ACCESSORIES (K882132)Charles Polo & Co., Inc.1988-06-15
LCA 2000 (K871034)Vistek Corp.1987-04-10
CHICK SURGICAL LIGHT (K862010)Professional Medical Products, Inc.1986-06-09
CAM-WRAP (K810292)Medline Industries, Inc.1981-03-04
DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 (K780162)Cavitron Corp.1978-03-27

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Every clearance here is in the API, with alerts when new ones post.