Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GEA — Predicate Candidate Screening
36 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
133 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003965 | MRI SAFE INSTRUMENTS | Aesculap, Inc. | 2001-03-16 | 84 | 0 |
| K982472 | GENICON TROCAR | Genicon, LC | 1999-02-04 | 204 | 1 |
| K954599 | CONMED TROGARD ELECTRONIC TROCAR SYSTEM | Conmedcorp | 1995-11-27 | 55 | 0 |
| K922460 | ORIGIN SECONDARY CANNULA AND TROCAR | Origin Medsystems, Inc. | 1992-09-16 | 113 | 0 |
| K920110 | ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE | ETHICON, Inc. | 1992-04-02 | 86 | 0 |
| K911262 | DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER | ETHICON, Inc. | 1991-06-20 | 90 | 0 |
| K904881 | DISPOSABLE YANKAUER SUCTION TUBE | Pilling Medical S.A. | 1991-03-06 | 133 | 0 |
| K903416 | CANNULA, SURGICAL | Advantage Diagnostics Corp. | 1990-11-23 | 116 | 0 |
| K904218 | SUCTION SYSTEM | Axiom Medical, Inc. | 1990-10-31 | 49 | 0 |
| K901717 | KLEIN MICRO-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 | 41 | 0 |
| K901718 | KLEIN LAMPREY-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 | 41 | 0 |
| K901719 | KLEIN MICRO-CANNULA HANDLE(TM) | Jeff Klein Surgical, Inc. | 1990-05-22 | 39 | 0 |
| K895684 | SOFT SUCTION ADAPTER | Applied Medical Technologies | 1989-11-20 | 60 | 0 |
| K896434 | AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* | United States Surgical, A Division of Tyco Healthc | 1989-11-16 | 7 | 0 |
| K895762 | CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC | Kolster Methods | 1989-10-18 | 22 | 0 |
| K895670 | SURGICAL SUCTION APPARATUS | Baker-Sundt Research, Inc. | 1989-09-27 | 8 | 0 |
| K880669 | L-5 PLASTIC SURGERY CANNULAS | American Instrument Manufacturer'S, Inc. | 1988-03-17 | 28 | 0 |
| K872214 | COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS | CooperVision, Inc. | 1987-08-17 | 69 | 0 |
| K872906 | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE | American Silk Sutures, Inc. | 1987-08-11 | 18 | 0 |
| K871384 | APEX SUCTION CURETTE | Apex Medical, Inc. | 1987-05-22 | 45 | 0 |
| K871043 | (I) LV AND (II) HV SERIES CANNULA | Celebration Medical Products, Inc. | 1987-04-23 | 37 | 0 |
| K863293 | DISPOSABLE SUCTION CANNULA NO. 902008-000 | Lifestream Int'L, Inc. | 1986-09-09 | 15 | 0 |
| K863150 | BOWEN CANNULA | Bowen & Company, Inc. | 1986-09-05 | 21 | 0 |
| K862936 | NEWMAN CANNULAE SYSTEM (NCS) | Byron Medical | 1986-08-14 | 10 | 0 |
| K861306 | SUCTION SYSTEM | Axiom Medical, Inc. | 1986-06-09 | 62 | 0 |
| K854005 | DEDO SUCTION CANNULA | Dedo Manufacturer, Inc. | 1985-12-06 | 67 | 0 |
| K844874 | PENNINE LINK YANKAUERS | Pennine Medical , Ltd. | 1985-06-06 | 171 | 0 |
| K843468 | PHARMA-PLAST SUCTION SET TYPE YANKAUER | Zimmar Consulting , Ltd. | 1984-11-23 | 78 | 0 |
| K843187 | CANNULA | ETHICON, Inc. | 1984-10-31 | 79 | 0 |
| K833377 | MEDICALEX | Medicalex | 1984-09-27 | 364 | 0 |
| K841249 | SUCTION CANNULAS | Custom Surgical Products, Inc. | 1984-06-04 | 75 | 0 |
| K833717 | PADGETT SUCTION CANNULA | Advanced Biosearch Assn. | 1983-12-14 | 54 | 0 |
| K832521 | PLASTIC SUCTION TIPS | Wells Johnson Co. | 1983-10-20 | 73 | 0 |
| K832520 | SUCTION TIPS | Wells Johnson Co. | 1983-10-20 | 73 | 0 |
| K832636 | FRAZIER SUCTION INSTRUMENT-DISPOS | Pilling Co. | 1983-10-14 | 71 | 0 |
| K810627 | MODEL 1301 BIOTAC (TM) | Progress Mankind Technology | 1981-04-02 | 24 | 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