Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HET — Predicate Candidate Screening
338 FDA 510(k) clearances under this product code; the 50 most recent screened below.
151 daysmedian FDA review time
498 days90th percentile
338clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | 2025-08-29 | 154 | 0 |
| K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | 2025-04-25 | 134 | 0 |
| K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | 2022-12-12 | 189 | 0 |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-13 | 267 | 0 |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | 2021-09-17 | 442 | 1 |
| K210104 | SurroundScope System | 270surgical , Ltd. | 2021-07-08 | 175 | 0 |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; El | Schoelly Fiberoptic GmbH | 2021-03-12 | 270 | 0 |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | 2020-08-21 | 206 | 0 |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2020-04-03 | 24 | 0 |
| K190190 | WV1 Endoscope | 270surgical , Ltd. | 2019-11-01 | 273 | 0 |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019-08-29 | 160 | 1 |
| K172796 | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | 2018-01-18 | 125 | 0 |
| K173111 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2017-11-28 | 60 | 0 |
| K163320 | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | 2017-03-21 | 118 | 0 |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 S | KARL STORZ Endoscopy-America, Inc. | 2015-11-20 | 263 | 0 |
| K151011 | VISERA 4K UHD SYSTEM | Olympus Medical Systems Corp. | 2015-10-01 | 169 | 0 |
| K131656 | MORCELLEX SIGMA GENERATOR | ETHICON, Inc. | 2013-09-27 | 113 | 0 |
| K123365 | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | Olympus Medical Systems Corp. | 2013-03-01 | 121 | 0 |
| K111425 | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | Olympus Medical Systems Corp. | 2012-04-20 | 333 | 1 |
| K111788 | ENDOEYE HD II | Olympus America, Inc. | 2012-01-13 | 203 | 2 |
| K101458 | LINA XCISE MODEL MOR-1515 | Lina Medical Aps | 2011-03-11 | 289 | 0 |
| K091010 | TROKAMED MORCELLATOR | Trokamed GmbH | 2011-03-01 | 691 | 1 |
| K100280 | GYNCARE MORCELLEX TISSUE MORCELLATOR | ETHICON, Inc. | 2010-03-24 | 51 | 0 |
| K080365 | MORCE POWER PLUS AND VARIOCARVE MORCELLATOR | NOUVAG AG | 2009-06-29 | 504 | 0 |
| K081173 | ENDOSCOPIC CO2 REGULATION UNIT UCR | Olympus Medical Systems Corporation | 2008-12-23 | 243 | 0 |
| K082451 | STRYKER VIDEOSCOPE | Stryker Endoscopy | 2008-12-16 | 113 | 0 |
| K080948 | HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH | Olympus Medical Systems Corporation | 2008-09-26 | 176 | 0 |
| K062097 | VERESS CANNULA AND MODULAR VERESS CANNULA | PAJUNK GmbH Medizintechnologie | 2006-10-13 | 81 | 0 |
| K062169 | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS | Applied Medical Resources Corp. | 2006-08-24 | 24 | 0 |
| K061268 | G-LIX TISSUE GRASPER | Usgi Medical | 2006-07-31 | 87 | 0 |
| K061050 | GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0 | ETHICON, Inc. | 2006-07-14 | 88 | 1 |
| K050404 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC I | Intuitive Surgical, Inc. | 2005-04-21 | 63 | 0 |
| K043013 | MILTEX LAPAROSCOPIC INSTRUMENTS | Miltex, Inc. | 2005-03-04 | 122 | 0 |
| K041321 | VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM | Richard Wolf Medical Instruments Corp. | 2004-07-09 | 52 | 0 |
| K040295 | APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS | Applied Medical Resources Corp. | 2004-03-12 | 32 | 0 |
| K033177 | POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX | Gunter Bissinger Medizintechnik GmbH | 2004-03-11 | 162 | 0 |
| K021237 | COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS | CooperSurgical, Inc. | 2003-04-10 | 357 | 0 |
| K022384 | XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP | Isolux America | 2002-10-18 | 88 | 0 |
| K022748 | REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS | Medical Device Services | 2002-10-09 | 51 | 0 |
| K020143 | VASOVIEW 5 HARVESTING CANNULA | Guidant Corporation, Cardiac Surgery | 2002-02-20 | 35 | 1 |
| K003805 | GYNECOLOGICAL LAPAROSCOPES | Global Endoscopy, Inc. | 2001-07-22 | 226 | 0 |
| K010510 | BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG | A & A Medical, Inc. | 2001-05-16 | 84 | 0 |
| K003417 | MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERES | Richard Wolf Medical Instruments Corp. | 2001-04-04 | 153 | 0 |
| K003164 | TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM | Richard Wolf Medical Instruments Corp. | 2001-01-08 | 90 | 0 |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Xomed, Inc. | 2000-06-09 | 224 | 0 |
| K001220 | ENDOPATH SURESEAL REDUCER CAP | Ethicon Endo-Surgery, Inc. | 2000-05-16 | 29 | 0 |
| K000199 | CORTEK MINI LAPAROSCOPE | Cortek Endoscopy, Inc. | 2000-04-13 | 83 | 0 |
| K992481 | CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 2000-03-17 | 235 | 0 |
| K992513 | THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070C | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 2000-03-17 | 235 | 0 |
| K993801 | GYNECARE LAPAROSCOPIC MORCELLATOR | ETHICON, Inc. | 2000-02-07 | 90 | 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