Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FQH — Predicate Candidate Screening
53 FDA 510(k) clearances under this product code; the 50 most recent screened below.
93 daysmedian FDA review time
340 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026-02-25 | 75 | 0 |
| K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (91012 | Bd | 2026-02-20 | 141 | 0 |
| K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023-06-15 | 65 | 0 |
| K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | 2023-05-25 | 436 | 0 |
| K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | 2023-05-16 | 410 | 0 |
| K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022-10-14 | 144 | 0 |
| K222804 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2022-09-22 | 6 | 0 |
| K210987 | IRRIGO Wound Wash Jet System | Inopro, Inc. | 2022-05-31 | 425 | 0 |
| K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022-03-23 | 128 | 0 |
| K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021-05-28 | 93 | 0 |
| K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020-12-14 | 130 | 0 |
| K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020-10-23 | 88 | 0 |
| K192349 | Bactisure Wound Lavage | Next Science, LLC | 2020-01-23 | 147 | 0 |
| K161165 | Next Science Irrigation Solution | Next Science, LLC | 2016-09-07 | 135 | 0 |
| K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | 2015-07-15 | 258 | 0 |
| K113312 | HY-CHLO(TM)WOUND SCRUB | Patrin Pharma | 2012-08-21 | 286 | 0 |
| K111313 | EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATI | Alcavis Hdc, LLC | 2011-12-14 | 218 | 0 |
| K110958 | VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / | Smith & Nephew, Inc. | 2011-08-01 | 118 | 0 |
| K090848 | PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM | Premier Brands of America, Inc. | 2009-06-17 | 79 | 0 |
| K082858 | EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER | Alcavis International, Inc. | 2009-05-27 | 240 | 0 |
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM | Irrimax Corporation | 2009-02-04 | 322 | 0 |
| K072404 | ERBE ERBEJET 2 SYSTEM | Erbe USA, Inc. | 2007-10-31 | 65 | 0 |
| K060782 | VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE | Smith & Nephew Wound Management | 2006-04-12 | 21 | 0 |
| K033590 | ERBE HELIX HYDRO-JET | Erbe USA, Inc. | 2004-01-30 | 81 | 0 |
| K021813 | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM | Hydrocision, Inc. | 2003-05-09 | 340 | 0 |
| K022613 | HELIX HYDRO-JET | Erbe USA, Inc. | 2002-10-25 | 80 | 0 |
| K012464 | HELIX HYDRO-JET | Andreas Pein Medizintechnik GmbH | 2001-10-10 | 70 | 0 |
| K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM | Hydrocision, Inc. | 2001-06-22 | 28 | 0 |
| K991383 | HYDROCISION DEBDRIDEMENT SYSTEM | Hydrocision, Inc. | 2000-03-31 | 345 | 0 |
| K983135 | BLOWER/MISTER | Cardiothoracic Systems, Inc. | 1998-11-13 | 66 | 0 |
| K974568 | CHASE ANASTOMOSIS VISUALIZATION DEVICE | Chase Medical, Inc. | 1998-01-06 | 32 | 0 |
| K973803 | FLEXVIEW CO2 BLOWER WITH MIST | Ethicon Endo-Surgery, Inc. | 1997-12-16 | 71 | 0 |
| K973485 | CLEARVIEW BLOWER/MISTER | Dlp, Inc. | 1997-12-08 | 84 | 1 |
| K972551 | ARTISAN PULSE LAVAGE SYSTEM | Howmedica Corp. | 1997-10-29 | 113 | 0 |
| K972069 | STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION | Stryker Instruments | 1997-07-29 | 56 | 7 |
| K970916 | H.V. PULSE LAVAGE (L31 SERIES) | Global Medical Products, Inc. | 1997-06-20 | 100 | 0 |
| K951666 | STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SH | Stryker Instruments | 1995-09-19 | 162 | 0 |
| K942886 | SIMPULSE SOLO SUCTION IRRIGATOR | Davol Inc., Sub. C. R. Bard, Inc. | 1994-07-19 | 32 | 0 |
| K933742 | TOP GUN | Bio-Medical Devices, Inc. | 1994-04-07 | 247 | 0 |
| K926337 | BONE LAVAGE SYSTEM | Innovative Surgical Devices Corp. | 1993-06-11 | 176 | 0 |
| K922083 | RMI SURGICCAL SITE VISUALIZATION WAND | Research Medical, Inc. | 1993-01-29 | 270 | 0 |
| K913568 | SURGI-SPRAY O.R. IRRIGATION SYSTEM | Phoenix Surgical Products, Inc. | 1991-11-01 | 84 | 0 |
| K874022 | PHARMASEAL WOUND IRRIGATION DEVICE | American Pharmaseal Div. Ahsc | 1987-12-30 | 89 | 0 |
| K874504 | MICRO-AIRE PULSE LAVAGE | Micro-Aire Surgical Instruments, Inc. | 1987-12-29 | 57 | 0 |
| K873466 | EXCEL PULSED IRRIGATION/SUCTION SYSTEM | Stryker Corp. | 1987-11-06 | 70 | 0 |
| K854737 | SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG | Orthopaedic Devices , Ltd. | 1986-05-19 | 174 | 0 |
| K854543 | PULSE LAVAGE | Tava Surgical Instruments | 1986-01-27 | 75 | 0 |
| K830386 | DAVOL SURGICAL SUCTION IRRIGATION INSTR | C.R. Bard, Inc. | 1983-03-29 | 53 | 0 |
| K820661 | MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG | Micro-Aire Surgical Instruments, Inc. | 1982-04-21 | 42 | 0 |
| K813607 | ACKRAD N-DO VAGE TUBE | Ackrad Laboratories | 1982-02-05 | 38 | 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