Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GCX — Predicate Candidate Screening
87 FDA 510(k) clearances under this product code; the 50 most recent screened below.
74 daysmedian FDA review time
200 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042454 | STRYKER CASSETTE PUMP | Stryker Endoscopy | 2004-12-09 | 90 | 4 |
| K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | Circon Corp. | 1999-08-03 | 41 | 0 |
| K972074 | SUCTION INSTRUMENTATION | Walter Lorenz Surgical, Inc. | 1997-07-25 | 52 | 0 |
| K971022 | CHASE SUCKER | Chase Medical, Inc. | 1997-04-17 | 28 | 1 |
| K964127 | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE | Allegiance Healthcare Corp. | 1996-12-31 | 77 | 0 |
| K964519 | CURITY THORACENTESIS TRAY | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-12-20 | 38 | 0 |
| K963648 | STRYKER SUCTION REGULATOR | Stryker Endoscopy | 1996-11-26 | 75 | 0 |
| K962920 | RENTON SUCTION DEVICE U.S. PATENT*4,767,404 | R&S Surgical, LLC | 1996-10-21 | 87 | 0 |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Medcare Medical Group, Inc. | 1996-07-19 | 65 | 0 |
| K960223 | CPR YANKAUER | Custom Pack Reliability | 1996-03-28 | 72 | 0 |
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Medcare Custom Packaging, Inc. | 1996-01-19 | 87 | 0 |
| K954726 | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) | Stryker Endoscopy | 1995-11-29 | 118 | 21 |
| K952219 | SUCTION TIP CLEANER CUP | Moore/Gobel | 1995-11-15 | 188 | 0 |
| K951119 | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-13 | 95 | 0 |
| K950464 | SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR | Sscor | 1995-04-25 | 81 | 0 |
| K931548 | INAMED DEVELOPMENT ASPIRATION TIP | Inamed Development Co. | 1994-01-10 | 287 | 0 |
| K924570 | OEM MULTI-VAC POWERED SUCTION PUMP | Oem Medical Div. | 1993-08-05 | 329 | 0 |
| K920912 | THE MEDIC TM | Medical and Environment Designs, Inc. | 1993-07-30 | 519 | 0 |
| K924337 | PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS | Deknatel, Inc. | 1993-07-28 | 335 | 0 |
| K924577 | MEDIVAC | Medisonic U.S.A., Inc. | 1993-03-23 | 194 | 0 |
| K911238 | TAHOE SUCTION IRRIGATOR | Tahoe Pro Instruments | 1992-11-27 | 618 | 0 |
| K920248 | MODEL SLASE 210 HOLMIUM LASER SYSTEM | Sunrise Technologies, Inc. | 1992-07-21 | 182 | 0 |
| K914601 | SUCTION CONNECTING TUBING | Bemis Mfg. Co. | 1992-02-07 | 119 | 0 |
| K912753 | XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL | Xomed-Treace, Inc. | 1991-09-23 | 91 | 0 |
| K910377 | COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM | CooperSurgical, Inc. | 1991-04-19 | 80 | 0 |
| K910218 | LAPAROMED CHOLANGIOGRAM VACUUM DEVICE | Laparomed Corp. | 1991-04-08 | 81 | 0 |
| K905448 | THORA-KLEX CHEST DRAINAGE UNIT | Davol, Inc. | 1991-03-27 | 112 | 0 |
| K895859 | CONTAIN(TM) | Arbor Technologies, Inc. | 1991-02-07 | 492 | 0 |
| K896134 | ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. | Goosen Enterprises, Inc. | 1990-08-30 | 310 | 0 |
| K901937 | CODMAN SUCTION PATTIE | Codman & Shurtleff, Inc. | 1990-07-16 | 77 | 0 |
| K902089 | EQUI-GUARD (ASPIRATOR FILTER) | Equi-Tron Mfg., Inc. | 1990-07-06 | 58 | 0 |
| K896804 | MANIFOLD | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-08 | 69 | 0 |
| K896558 | YANKAUER SUCTION TUBE-RIGID TYPE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896556 | UNIVERSAL POOLE SUCTION TUBE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896563 | TUBING CONNECTORS | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896557 | YANKAUER SUCTION TUBE-FLEXIBLE TYPE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896562 | STOPCOCK | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K894695 | VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM | Medistad Corp. | 1990-01-22 | 182 | 0 |
| K895039 | STERILE SALINE - FOR SUCTION CATHETER LUBRICATION | Aplicare, Inc. | 1989-10-03 | 55 | 0 |
| K893649 | MECONIUM ASPIRATOR | Gish Biomedical, Inc. | 1989-08-21 | 98 | 0 |
| K893741 | RECEPTAL (R) SAF-GARD(TM) SUCTION LINER | Abbott Laboratories | 1989-08-17 | 92 | 0 |
| K892549 | SUCTION TUBES: HOUSE, BARON | Zinnanti Surgical Instruments, Inc. | 1989-05-18 | 37 | 0 |
| K890129 | PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM | Deknatel, Inc. | 1989-04-10 | 88 | 0 |
| K890431 | PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN | Deknatel, Inc. | 1989-04-04 | 67 | 0 |
| K885208 | RECEPTAL SAF-GARD(TM) SYSTEM | Abbott Laboratories | 1989-03-17 | 88 | 0 |
| K885334 | VAC-RITE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-03-08 | 70 | 0 |
| K884103 | REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES | Boehringer Laboratories | 1989-03-03 | 155 | 0 |
| K881252 | PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE | Deknatel, Inc. | 1988-06-17 | 86 | 0 |
| K874505 | CONTAIN(TM) | Arbor Technologies, Inc. | 1988-05-20 | 200 | 0 |
| K870874 | CSPI SPECIMEN TRAP (NON-STERILE) | Custom Surgical Products, Inc. | 1988-04-19 | 413 | 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