Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GBX — Predicate Candidate Screening
77 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
254 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131659 | MOERAE VEIN PREPARATION KIT | Moerae Matrix, Inc. | 2014-03-03 | 270 | 0 |
| K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | Maquet Cardiovascular, LLC | 2008-12-17 | 91 | 1 |
| K052286 | DEUTSCH ANTI-BLOCKAGE WOUND DRAIN | The Catheter Exchange, Inc. | 2005-10-21 | 60 | 0 |
| K043515 | GRAFTSAVER | Vescare, Inc. | 2005-03-31 | 101 | 0 |
| K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P | Misonix, Inc. | 2002-01-10 | 87 | 0 |
| K000704 | DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) | Dmc Medical, Ltd. | 2000-05-19 | 78 | 0 |
| K974233 | LYSONIX IRRIGATION SYSTEM | Lysonix, Inc. | 1998-02-03 | 83 | 0 |
| K973703 | JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMAD | Allegiance Healthcare Corp. | 1997-12-04 | 69 | 0 |
| K972635 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-10-01 | 79 | 0 |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | Axiom Medical, Inc. | 1997-03-10 | 77 | 0 |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT T | Sil-Med Corp. | 1996-06-26 | 83 | 0 |
| K961147 | CLOSED FLUID COLLECTION SYSTEM | B.Braun Medical, Inc. | 1996-05-31 | 71 | 0 |
| K960955 | JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING | Baxter Healthcare Corp | 1996-05-22 | 72 | 0 |
| K955339 | HYDROLOGY 5000 | Northgate Technologies, Inc. | 1996-03-13 | 114 | 0 |
| K955474 | NEO-PNEUMOCATH | Intra Special Catheters GmbH | 1996-02-13 | 75 | 0 |
| K955505 | OPTI-DRAIN MULTI-USE DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1996-02-07 | 68 | 0 |
| K955439 | THE REEL THING (MODIFICATION) | Biomedical Devices, Inc. | 1995-12-26 | 43 | 0 |
| K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN | Sil-Med Corp. | 1995-05-24 | 876 | 0 |
| K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1995-05-15 | 21 | 0 |
| K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | Navarre Biomedical , Ltd. | 1995-04-24 | 25 | 0 |
| K950437 | ANGIOCATH SIDEHOLDER DRAINAGE CATHETER | Becton Dickinson Vascular Access, Inc. | 1995-03-14 | 40 | 0 |
| K950439 | INSYTE SIDEHOLDED DRAINAGE CATHETER | Becton Dickinson Vascular Access, Inc. | 1995-03-14 | 40 | 0 |
| K942335 | ACI SILICATH THORACIC CATHETER | American Catheter | 1994-08-09 | 85 | 0 |
| K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER | Deknatel, Inc. | 1994-07-27 | 649 | 0 |
| K940156 | THE REEL THING | Bio-Medical Devices, Inc. | 1994-06-07 | 146 | 0 |
| K942274 | ORION SUCTION CATHETER KIT WITH STERILE SALINE | Regulatory & Marketing Services, Inc. | 1994-06-02 | 23 | 0 |
| K942273 | ORION SUCTION CATHETER KIT WITH STERILE WATER | Regulatory & Marketing Services, Inc. | 1994-06-02 | 23 | 0 |
| K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP | Puritas Health Care, Inc. | 1994-05-05 | 170 | 0 |
| K940352 | STORZ N5941 SERIES MEDICAL GRADE TUBING | Storz Instrument Co. | 1994-04-14 | 79 | 0 |
| K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS | Navarre Biomedical , Ltd. | 1994-03-28 | 244 | 0 |
| K926495 | SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE | Sil-Med Corp. | 1994-02-02 | 400 | 0 |
| K926408 | SIL-SLIP FLAT SUCTION DRAIN | Sil-Med Corp. | 1994-02-02 | 408 | 0 |
| K932391 | NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET | Navarre Biomedical , Ltd. | 1994-01-27 | 254 | 0 |
| K932205 | ERCP CATHETER, HYDROPHILIC COATED | Wilson-Cook Medical, Inc. | 1994-01-03 | 242 | 1 |
| K925117 | URESIL ABSCESS DRIANAGE AND IRRIGATION SET | Uresil Corp. | 1993-08-11 | 306 | 0 |
| K926109 | FLUID DRAINAGE TRAY | Symbiosis Corp. | 1993-06-07 | 186 | 0 |
| K930551 | KENDALL UNIVERSAL EXTENSION SET | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-05-12 | 98 | 0 |
| K923667 | IRRIGATION/SUCTION PROBE | Surgical Instrument, Inc. | 1993-04-23 | 275 | 0 |
| K925176 | VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE | Boston Scientific Corp | 1993-04-08 | 176 | 0 |
| K925805 | KENDALL WOUND DRAINAGE SYSTEMS-TROCARS | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-02-26 | 102 | 0 |
| K925748 | KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-01-13 | 61 | 0 |
| K924702 | TURKEL ABDOMINAL PARACENTESIS SYSTEM | Symbiosis Corp. | 1993-01-12 | 117 | 0 |
| K925533 | ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET | Angeion Corp. | 1993-01-12 | 71 | 0 |
| K921424 | SIL-MED FLAT SUCTION DRAIN | Sil-Med Corp. | 1992-09-28 | 188 | 0 |
| K922739 | HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE | Hollister, Inc. | 1992-08-06 | 59 | 0 |
| K921934 | INTRADUCER | Taut, Inc. | 1992-07-15 | 82 | 0 |
| K921095 | PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT | Pacer Tool & Plastics, Inc. | 1992-04-29 | 54 | 0 |
| K913542 | THORACIC CATHETER WITH GUIDE | Intl. Medical Devices , Ltd. | 1992-01-21 | 165 | 0 |
| K913539 | THORACIC CATHTER STYLET | Intl. Medical Devices , Ltd. | 1992-01-21 | 165 | 0 |
| K910245 | I/A HANDPIECE WITH REPLACEABLE TIPS | Surgical Technologies, Inc. | 1991-04-22 | 90 | 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