Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GAZ — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
34 daysmedian FDA review time
115 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952605 | SUCTION/IRRIGATOR TUBING KIT | Surgical Laser Technologies, Inc. | 1995-09-15 | 101 | 0 |
| K945978 | TUBING, NONINVASIVE | Endoscopic Technologies, Inc. | 1995-01-11 | 34 | 0 |
| K930512 | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES | Core Dynamics, Inc. | 1993-07-23 | 172 | 0 |
| K911865 | NORTEC CONNECTING TUBE SET | North American Sterilization & Packaging Co. | 1991-11-01 | 189 | 0 |
| K910471 | MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE | Baxter Healthcare Corp | 1991-03-08 | 32 | 0 |
| K910171 | MAXI-FLOW SUCTION SET W/Y CONNECTOR | Adler Instrument Co. | 1991-02-01 | 17 | 0 |
| K910170 | MAXI-FLOW SUCTION SET 12 FT. | Adler Instrument Co. | 1991-02-01 | 17 | 0 |
| K882315 | VIR-A-VAC EMPTY | Viratec Corp. | 1988-09-26 | 115 | 0 |
| K883473 | SURGICAL CONNECTING TUBES | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-08-25 | 9 | 0 |
| K864964 | 5 - IN - 1 CONNECTOR | Medovations, Inc. | 1987-01-20 | 29 | 0 |
| K861757 | 5 IN 1 CONNECTOR | Jackson Plastics, Inc. | 1986-06-06 | 31 | 0 |
| K843476 | PHARMA-PLAST SMOOTH BORE CONNECTORS | Zimmar Consulting , Ltd. | 1984-09-24 | 18 | 0 |
| K840838 | MMG CONNECTIVE TUBING | Medical Marketing Group | 1984-03-30 | 35 | 0 |
| K832519 | ASPIRATING TUBING | Wells Johnson Co. | 1983-10-20 | 73 | 0 |
| K830835 | STERILE 5 IN 1 CONNECTORS | Abco Dealers, Inc. | 1983-04-06 | 21 | 0 |
| K830901 | CONNECTOR 5 IN 1, T-CONNECTOR | Medical Specialists IN Packaging | 1983-04-06 | 16 | 0 |
| K830381 | STERILE SAFETY PINS | Devon Industries, Inc. | 1983-03-24 | 48 | 0 |
| K820004 | PLEUROFIX THORACENTESIS KIT | Burron Medical Products, Inc. | 1982-02-04 | 31 | 0 |
| K802777 | ARGYLE CONNECT TUBE-CON & NON | Sherwood Medical Co. | 1980-12-11 | 36 | 0 |
| K802761 | LATEX PENROSE TUBING CAT. #20400,414,416 | American Hospital Supply Corp. | 1980-11-19 | 15 | 0 |
| K790358 | FLUID ADMINISTRATION CAT.#14-923 | Norton Performance Plastics Corp. | 1979-03-21 | 36 | 0 |
| K790209 | FILTER SYSTEM, ALTNER DISPOSABLE | Orthopedic Equipment Co., Inc. | 1979-02-26 | 27 | 0 |
| K781127 | CONNECTING TUBE, CONDUCTIVE, SURG. | Seamless Hospital Products Co. | 1978-09-20 | 77 | 0 |
| K780985 | PVC LINES FOR MONITORING | Norton Performance Plastics Corp. | 1978-07-27 | 43 | 0 |
| K780417 | ASEPTIC TRANSFER SET | Heyer Schulte Corp. | 1978-04-18 | 35 | 0 |
| K770920 | THORACIC DRAINAGE SET, ARGYLE DUAL | Sherwood Medical Industries | 1977-06-24 | 35 | 0 |
| K760202 | TUBE, STERILE CONDUCTIVE CONNECTING | Ipco Corp. | 1976-07-19 | 11 | 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