Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FYD — Predicate Candidate Screening
75 FDA 510(k) clearances under this product code; the 50 most recent screened below.
176 daysmedian FDA review time
328 days90th percentile
75clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240127 | PlumeSafe X5 Smoke Management System | Conmed Corporation | 2024-08-05 | 201 | 0 |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | 2024-04-10 | 134 | 0 |
| K213068 | Medline Smoke Evacuation Shroud | Medline Industries, Inc. | 2022-01-03 | 102 | 0 |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Northgate Technologies, Inc. | 2021-03-25 | 176 | 0 |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Tr | Megadyne Medical Products, Inc. | 2020-06-26 | 144 | 0 |
| K192035 | EvaQMax Smoke Evacuation System | Bio Protech, Inc. | 2019-08-29 | 30 | 0 |
| K191328 | Megadyne Foot Switch | Megadyne Medical Products, Inc. | 2019-07-26 | 71 | 0 |
| K182224 | SafeAir Smoke Evacuator compact | Lina Medical Aps | 2019-02-07 | 175 | 0 |
| K173108 | Smoklean | Sejong Medical Co., Ltd. | 2018-05-18 | 231 | 0 |
| K163659 | Crystal Vision | I.C Medical, Inc. | 2017-10-30 | 307 | 0 |
| K142335 | RapidVac Smoke Evacuator System | Covidien | 2015-01-14 | 146 | 0 |
| K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | Buffalo Filter Co., Inc. | 2014-03-03 | 292 | 0 |
| K091139 | CONMED AER DEFENSE SMOKE EVACUATOR | Conmed Corporation | 2009-05-05 | 15 | 0 |
| K053464 | SERVICE MANAGER SM40SE | Conmed Integrated Systems, Canada, Ulc | 2006-06-06 | 175 | 0 |
| K052797 | LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM | Medtek Devices, Inc. | 2006-02-13 | 133 | 0 |
| K043494 | MASTEL LASER CLEAN ROOM, MODEL EBS-100 | Mastel Precision Surgical Instruments, Inc. | 2005-10-04 | 291 | 0 |
| K032400 | LAFACI | Vision Pro, LLC | 2004-05-07 | 277 | 0 |
| K020510 | SMOKE EVACUATION HOSES/TUBING | Dm Medical, Inc. | 2002-05-03 | 77 | 0 |
| K012991 | NEPTUNE WASTE MANAGEMENT STSTEM | Stryker Instruments | 2001-11-29 | 84 | 6 |
| K003840 | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES | I.C Medical, Inc. | 2001-02-01 | 51 | 0 |
| K001082 | STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 | Stackhouse, Inc. | 2000-06-15 | 72 | 14 |
| K000904 | PENADAPT 10 | Buffalo Filter Co., Inc. | 2000-06-08 | 79 | 0 |
| K990037 | NEPTUNE WASTE MANAGEMENT SYSTEM | American Immuno Tech | 1999-08-24 | 230 | 2 |
| K992361 | PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL | Pall Medical | 1999-08-20 | 36 | 0 |
| K983298 | BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFA | Buffalo Filter Co., Inc. | 1999-08-16 | 329 | 1 |
| K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 | Buffalo Filter Co., Inc. | 1999-08-11 | 322 | 0 |
| K983364 | BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 | Buffalo Filter Co., Inc. | 1999-08-11 | 321 | 0 |
| K991167 | STERIS SMOKE EVACUATION SYSTEM | STERIS Corporation | 1999-06-03 | 57 | 0 |
| K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM | Valleylab, Inc. | 1998-06-29 | 110 | 0 |
| K973610 | SKYVAL | Pyramid Air Systems | 1997-12-19 | 88 | 0 |
| K970352 | SMARTVAC SMOKE EVACUATION SYSTEM | Isomedix Operations, Inc. | 1997-11-04 | 278 | 0 |
| K952981 | FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC | Utah Medical Products, Inc. | 1995-08-28 | 61 | 0 |
| K943226 | BUFFALO FILTER REPLACEMENT FILTER #BSPF030 | Buffalo Filter Co., Inc. | 1995-07-10 | 369 | 0 |
| K943227 | BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 | Buffalo Filter Co., Inc. | 1995-07-07 | 366 | 0 |
| K940266 | BEI MEDICAL SYSTEMS' SMOKE EVACUATOR | Bei Medical Systems Co., Inc. | 1994-03-24 | 62 | 0 |
| K935439 | SNJ SMOKE EVACUATION SUCTION WAND | Lca, Inc. | 1994-03-07 | 115 | 0 |
| K932230 | CRYSTAL VISION AND ACCESSORIES | I.C Medical, Inc. | 1994-02-18 | 287 | 0 |
| K930043 | ACU-EVAC | Acuderm, Inc. | 1994-02-09 | 400 | 0 |
| K930058 | BUFFALO FILTER REPLACEMENT FILTER #BPTU100 | Buffalo Filter Co., Inc. | 1993-11-30 | 328 | 0 |
| K930062 | BUFFALO FILTER REPLACEMENT FILTER #BST300UL | Buffalo Filter Co., Inc. | 1993-11-30 | 328 | 0 |
| K930167 | REUSABLE TOWEL AND GOWN PACKS | Custom Sterile Services, Inc. | 1993-11-30 | 321 | 0 |
| K930434 | PLUMEMASTER SMOKE EVACUATION SYSTEM | Sorenson Laboratories, Inc. | 1993-11-16 | 294 | 0 |
| K930063 | BUFFALO FILTER REPLACEMENT FILTER #BCULPA | Buffalo Filter Co., Inc. | 1993-11-12 | 310 | 0 |
| K930066 | BUFFALO FILTER REPLACEMENT FILTER #BCCHAR | Buffalo Filter Co., Inc. | 1993-11-12 | 310 | 0 |
| K930064 | BUFFALO FILTER REPLACEMENT FILTER #BCR0030 | Buffalo Filter Co., Inc. | 1993-11-12 | 310 | 0 |
| K930060 | BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO | Buffalo Filter Co., Inc. | 1993-11-12 | 310 | 0 |
| K930065 | BUFFALO FILTER REPLACEMENT FILTER #BCR0043 | Buffalo Filter Co., Inc. | 1993-11-12 | 310 | 0 |
| K930041 | VICROSAFE 6 AND VICROSAFE 12 | Buffalo Filter Co., Inc. | 1993-11-03 | 302 | 0 |
| K930040 | BUFFALO FILTER REPLACEMENT #BLFS-101/103 | Buffalo Filter Co., Inc. | 1993-11-02 | 301 | 0 |
| K930061 | BUFFALO FILTER REPLACEMENT FILTER BST312PF | Buffalo Filter Co., Inc. | 1993-11-02 | 300 | 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