Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HIF — Predicate Candidate Screening
178 FDA 510(k) clearances under this product code; the 50 most recent screened below.
144 daysmedian FDA review time
412 days90th percentile
178clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C | Weyo Surgical Technology , Ltd. | 2026-06-25 | 314 | 0 |
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2026-04-16 | 265 | 0 |
| K250388 | ENDOFLATOR + | Karl Storz SE & CO. KG | 2025-09-22 | 223 | 0 |
| K242772 | AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. | 2025-04-11 | 210 | 0 |
| K243527 | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation | 2025-01-13 | 60 | 1 |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | 2024-10-15 | 50 | 0 |
| K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | 2024-05-02 | 261 | 0 |
| K232902 | EVA15 insufflator | Palliare , Ltd. | 2024-05-02 | 227 | 0 |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | 2024-01-12 | 112 | 0 |
| K232401 | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | 2023-12-14 | 126 | 0 |
| K231342 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2023-09-20 | 134 | 0 |
| K230239 | AirSeal iFS System; AirSeal dV Solution | Conmed Corporation | 2023-09-20 | 233 | 0 |
| K231407 | StarFin | Premium Medical Technology, LLC | 2023-08-29 | 106 | 0 |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | 2023-05-16 | 239 | 0 |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2023-03-28 | 265 | 0 |
| K222901 | EVA15 insufflator | Palliare , Ltd. | 2023-01-27 | 126 | 0 |
| K212786 | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | 2022-02-23 | 175 | 0 |
| K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifu | Conmed Corporation | 2021-08-19 | 128 | 0 |
| K202799 | EVA15 | Palliare , Ltd. | 2020-10-21 | 28 | 0 |
| K201361 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | 2020-07-29 | 68 | 0 |
| K193520 | EVA 15 Insufflator | Palliare , Ltd. | 2020-07-23 | 217 | 0 |
| K193339 | GTK Veress Needles | Guangzhou T.K Medical Instrument Co., Ltd. | 2020-01-30 | 59 | 0 |
| K191780 | AP50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2019-08-28 | 57 | 0 |
| K190303 | AirSeal | Conmed Corporation | 2019-03-28 | 44 | 0 |
| K172835 | GRI-Alleset Veress Needle | Gri Medical and Electronic Technology Co., Ltd. | 2018-06-11 | 265 | 0 |
| K172516 | SurgiQuest AIRSEAL iFS System | Conmed Corporation | 2018-03-16 | 207 | 0 |
| K173545 | TEMED Gas Diffuser | Temed | 2018-02-14 | 90 | 0 |
| K170799 | AP 50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2017-11-14 | 242 | 0 |
| K162582 | HumiGard Surgical Humidification System, HumiGard Humdified | Fisher & Paykel Healthcare | 2017-06-23 | 281 | 0 |
| K171139 | LaparoLight Veress Needle | Buffalo Filter, LLC | 2017-05-18 | 30 | 0 |
| K170784 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | 2017-05-15 | 61 | 0 |
| K161554 | ENDOFLATOR 40, ENDOFLATOR 50 | KARL STORZ Endoscopy-America, Inc. | 2017-03-02 | 269 | 0 |
| K162648 | U-Blade Veress Needle | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | 2016-12-12 | 81 | 0 |
| K153367 | S698 Symbioz flow | Sopro - Acteon Group | 2016-06-17 | 207 | 0 |
| K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | 2016-03-04 | 88 | 0 |
| K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015-07-31 | 199 | 0 |
| K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015-03-20 | 112 | 11 |
| K142700 | InsufflatOR Needle | Gynetech Pty. , Ltd. | 2014-12-19 | 88 | 0 |
| K140263 | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT | Lexion Medical, LLC | 2014-03-05 | 30 | 0 |
| K132203 | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA | Lexion Medical, LLC | 2013-09-20 | 66 | 0 |
| K132204 | INSUFLOW SYNERGY XL PORT | Lexion Medical, LLC | 2013-08-22 | 37 | 0 |
| K122180 | HIGH FLOW INSUFFLANTION UNIT | Olympus Medical Systems Corporation | 2012-11-13 | 113 | 1 |
| K120151 | NEBULAE I | Northgate Technologies, Inc. | 2012-08-17 | 212 | 0 |
| K120640 | INSUFLOW SYNERGY PORT | Lexion Medical, LLC | 2012-07-18 | 138 | 0 |
| K121336 | MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM | Surgiquest, Inc. | 2012-07-03 | 61 | 0 |
| K112975 | CARBONAID C02 DIFFUSER | Cardia Innovation AB | 2012-06-22 | 261 | 0 |
| K110294 | HIGH FLOW INSUFFLATION UNIT UHI-4 | Olympus Medical Systems Corporation | 2011-11-18 | 290 | 2 |
| K111955 | MEDLINE PNEUMOPERITONEUM NEEDLE | Medline Industries, Inc. | 2011-11-16 | 128 | 0 |
| K112357 | VESSEL GUARDIAN | Lexion Medical, LLC | 2011-11-10 | 86 | 0 |
| K111441 | UNIMAX VERESS NEEDLE | Unimax Medical Systems, Inc. | 2011-08-19 | 87 | 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