Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KGZ — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
89 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022306 | AART SILICONE TUBING | Aesthetic and Reconstructive Technologies, Inc. | 2002-10-10 | 86 | 0 |
| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | Byron Medical | 1998-02-10 | 88 | 0 |
| K973183 | WOUND DRAINAGE HOLDER | R & D Medical Products, Inc. | 1998-01-23 | 151 | 0 |
| K955433 | DURALASTIC SILICONE TUBING | Allied Biomedical Corp. | 1996-01-26 | 59 | 0 |
| K942315 | NAVARRE PERCUTANEOUS ACCESS SET | Navarre Biomedical , Ltd. | 1994-07-08 | 56 | 0 |
| K896087 | PALESTRANT IRRIGATION AND DRAINAGE SET | North American Instrument Corp. | 1989-11-03 | 15 | 0 |
| K895041 | OPTICAL CATHETER(TM) INTRODUCER SETS | Medical Dynamics, Inc. | 1989-10-16 | 68 | 0 |
| K893406 | DESERET PRN ADAPTER | Deseret Medical, Inc. | 1989-06-22 | 51 | 0 |
| K873009 | CONCEPT SWITCHING STICK | Concept, Inc. | 1987-08-17 | 13 | 0 |
| K870014 | HCI GENERAL PURPOSE CATHETER STYLET | Health Care Innovations, Inc. | 1987-02-06 | 35 | 0 |
| K864115 | TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU | Cathaid, Inc. | 1986-11-07 | 28 | 0 |
| K855078 | ANGIO MED DISPOSABLE PRESSURE CONNECTORS | Angiomed U.S., Inc. | 1986-02-19 | 62 | 0 |
| K842666 | NU-THOR THORACOSTOMY KIT | Intl. Medical Devices , Ltd. | 1984-09-20 | 72 | 0 |
| K821525 | DESERET UNIVERSAL LUER LOCK | Warner-Lambert Co. | 1982-06-23 | 33 | 0 |
| K821245 | DESERET OFFSET PRN ADAPTER | Warner-Lambert Co. | 1982-05-13 | 14 | 0 |
| K810530 | PERI-PATCH GLUE MOLD | Quinton, Inc. | 1981-03-24 | 26 | 0 |
| K810531 | PERI-PATCH PERITONEAL CATHETER EXTENSION | Quinton, Inc. | 1981-03-24 | 26 | 0 |
| K802367 | ARROW CATHETER CLAMP | Arrow Intl., Inc. | 1980-10-23 | 24 | 0 |
| K802286 | ARGLE LATEX PENROSE TUBING | Sherwood Medical Co. | 1980-10-23 | 34 | 0 |
| K791806 | CONPHAR ADAPT-CONNECTS STERILE, NONSTE. | Conphar, Inc. | 1979-09-21 | 8 | 0 |
| K791803 | CONPHAR CATHETER PLUG | Conphar, Inc. | 1979-09-21 | 8 | 0 |
| K790597 | SENSOMAT SIDEARM ADAPTER | Biochem International, Inc. | 1979-07-10 | 106 | 0 |
| K781846 | ADAPTER, CATHETER SHEATH | Arrow Intl., Inc. | 1978-12-12 | 41 | 3 |
| K781854 | PAD, B-D I.V. CATH. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-12-04 | 28 | 0 |
| K780259 | CATHETERIZATION TRAY & KIT | Argon Medical Corp. | 1978-04-18 | 62 | 0 |
| K770154 | 3-WAY STOPCOCK WITH LUER-LOCK FITTING | American Viggo | 1977-02-28 | 35 | 0 |
| K760384 | STOPPERS | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760385 | EXTENSION SETS | B. Braun Instruments | 1976-11-02 | 89 | 0 |
| K760383 | STOPCOCKS | B. Braun Instruments | 1976-11-02 | 89 | 6 |
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