Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FSY — Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
130 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142984 | Leo Minor | Sunnex, Inc. | 2014-10-29 | 13 | 0 |
| K142076 | CLAVEGUARD FREEDOM SURGICAL LIGHT | Dickson & Dickson Healthcare (Us), Inc. | 2014-09-30 | 61 | 0 |
| K140812 | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | Medical Illumination International, Inc. | 2014-08-07 | 128 | 0 |
| K132551 | ZF 720 | Umbel Corporation | 2014-06-30 | 320 | 0 |
| K140930 | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | Convida Healthcare & Systems Corporation | 2014-06-09 | 59 | 0 |
| K140460 | MACH LED 2SC | Dr. Mach GmbH & Co. KG | 2014-04-03 | 38 | 0 |
| K140461 | MACH LED 2MC | Dr. Mach GmbH & Co. KG | 2014-04-03 | 38 | 0 |
| K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | Stryker Communications | 2013-12-30 | 118 | 0 |
| K132307 | VIDA LED SURGICAL LIGHTING SYSTEM | Convida Healthcare & Systems Corporation | 2013-11-05 | 104 | 0 |
| K131893 | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGI | Ajw Technology Consultants, Inc. | 2013-10-30 | 127 | 0 |
| K122875 | ORICARE L2700 | Oricare, Inc. | 2012-12-18 | 90 | 0 |
| K120392 | CHROMOPHARE F 628 AND F 528 | Berchtold GmbH & Co. KG | 2012-02-16 | 8 | 2 |
| K102758 | TRULIGHT 5520 AND TRULIGHT 5320 | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2010-10-26 | 33 | 1 |
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | Burton Medical Products Corp. | 2010-09-30 | 119 | 0 |
| K100702 | STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=T | Huot Instruments, LLC | 2010-07-20 | 130 | 0 |
| K093009 | MACH LED SC | Dr. Mach GmbH & Co. KG | 2010-04-01 | 184 | 0 |
| K093010 | MACH LED MC | Dr. Mach GmbH & Co. KG | 2010-04-01 | 184 | 0 |
| K090378 | CHROMOPHARE E 668 | Berchtold GmbH & Co. KG | 2009-02-23 | 6 | 0 |
| K083323 | NUVO VERDE LED LIGHTING SYSTEM | Nuvo, Inc. | 2009-01-28 | 77 | 0 |
| K083066 | CHROMOPHARE E 778 AND E 558 | Berchtold Holding GmbH | 2008-10-30 | 15 | 0 |
| K080857 | CHROMOPHARE E-SERIES | Berchtold Holding GmbH | 2008-04-10 | 14 | 0 |
| K072072 | HARMONY LED-1 SURGICAL LIGHTING SYSTEM | STERIS Corporation | 2007-10-05 | 67 | 1 |
| K071698 | AURORA LED SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | 2007-07-06 | 15 | 4 |
| K070442 | POWERLED SURGICAL LIGHT SYSTEM | Maquet S.A. | 2007-03-16 | 29 | 2 |
| K063333 | M3 | Mavig GmbH | 2006-11-21 | 15 | 1 |
| K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006-06-22 | 42 | 6 |
| K060802 | VISUM LED SURGICAL LIGHTING SYSTEM | Stryker Communications Corp. | 2006-04-07 | 14 | 3 |
| K042395 | OUTPATIENT III MINOR SURGERY LIGHT | Burton Medical Products Corp. | 2004-12-01 | 90 | 0 |
| K042382 | DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO | Med-General Technologies, LLC | 2004-11-30 | 90 | 0 |
| K040735 | ALM X'TEN (X10) SURGICAL LIGHT SYSTEM | Alm S.A. | 2004-05-21 | 60 | 6 |
| K040015 | MODIFICATION TO PRISMALIX SURGICAL LIGHT | Alm S.A. | 2004-01-21 | 16 | 0 |
| K031068 | STRYKER VISUM SURGICAL LIGHTING SYSTEM | Stryker Endoscopy | 2003-08-12 | 130 | 8 |
| K031979 | CONMED INTEGRATED SYSTEMS NURSES ASSISTANT | Conmed Integrated Systems (Cmis) | 2003-07-25 | 29 | 0 |
| K030906 | AXCEL SURGICAL LIGHT | Alm | 2003-04-23 | 30 | 1 |
| K024132 | CHROMOPHARE X 65 | Berchtold Holding GmbH | 2003-03-21 | 95 | 0 |
| K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | Skytron, Div. the Kmw Group, Inc. | 2002-11-13 | 183 | 0 |
| K011693 | TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 | Trumpf Medical Systems, Inc. | 2001-06-13 | 13 | 3 |
| K010716 | VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SIN | Valmed Corp. | 2001-05-30 | 82 | 0 |
| K002463 | STELLAR | Skytron, Div. the Kmw Group, Inc. | 2000-11-08 | 90 | 0 |
| K000639 | VISIONARY 2000 | Burton Medical Products Corp. | 2000-05-25 | 90 | 0 |
| K993242 | CASTLE SURGICAL LIGHT, MODEL 3000 | Getinge/Castle, Inc. | 1999-11-08 | 42 | 0 |
| K992090 | MILLENNIUM GOLD | Skytron, Div. the Kmw Group, Inc. | 1999-09-08 | 79 | 0 |
| K990656 | CHROMOPHARE D 530 LDR SURGICAL LIGHT | Berchtold Holding GmbH | 1999-07-20 | 141 | 0 |
| K991527 | CHROMOPHARE D500, D530, D650 | Berchtold Holding GmbH | 1999-05-27 | 24 | 0 |
| K984611 | DRAGER SOLA SERIES, MODELS 1000/700/500/300 | Drager Medizintechnik GmbH | 1999-03-29 | 90 | 0 |
| K982063 | ALM PRISMALIX (PRX) SURGICAL LIGHT | Alm Surgical Equipment, Inc. | 1998-09-22 | 102 | 1 |
| K981081 | BRIGHTSTAR | Hill-Rom, Inc. | 1998-04-29 | 36 | 0 |
| K974084 | GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT | Getinge/Castle, Inc. | 1998-03-03 | 125 | 0 |
| K974433 | CHROMOPHARE D 500, CHROMOPHARE D 530 | Berchtold Holding GmbH | 1998-02-20 | 88 | 0 |
| K973466 | HANAULUX BLUE 75 AND HANAULUX BLUE 120 | Heraeus Med GmbH | 1997-10-24 | 70 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda