Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GAX — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
123 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931198 | UNIQUET | Icat Systems | 1993-09-01 | 176 | 0 |
| K881398 | TOURNIQUET | Barretta Products, Research and Development, Inc. | 1988-04-29 | 25 | 0 |
| K881176 | STERILE ESMARCH BANDAGE | Spectrum/Hydro-Med Products, Inc. | 1988-04-11 | 24 | 0 |
| K875092 | DEGANIA SILICONE TOURNIQUET | Degania Silicone , Ltd. | 1988-01-07 | 28 | 0 |
| K873928 | UNIVERSAL TOURNIQUET | Dryden Corp. | 1987-10-23 | 28 | 0 |
| K872003 | KINDERWRAP | The Kinder Co. | 1987-06-23 | 28 | 0 |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | Dale Medical Products, Inc. | 1987-01-12 | 28 | 0 |
| K853472 | FINGER TOURNIQUETTE | Joseph B. Marogil | 1985-10-10 | 51 | 1 |
| K853537 | VELCRO TOURNIQUET | Cp Medical | 1985-09-12 | 20 | 0 |
| K852277 | CATAPRESS TOURNIGUET | Boehringer Ingelheim Pharmaceuticals, Inc. | 1985-06-27 | 29 | 0 |
| K851482 | TOURNIQUET | Polymer Technology Corp. | 1985-04-29 | 14 | 0 |
| K843056 | ELASTIC BANDAGE | Sterile Medical Systems | 1984-12-04 | 123 | 0 |
| K840489 | DISPOSIQUET A DISPOS. TOURNIQUET | Med Lab Products | 1984-03-12 | 35 | 0 |
| K830467 | TOURNIQUET/LATEX TOURNIQUET | Primeline Industries, Inc. | 1983-03-31 | 44 | 0 |
| K822553 | PRESSURE-QUET TOURNIQUET | Nutec Med, Inc. | 1982-09-17 | 24 | 0 |
| K821700 | LATEX PENROSE DRAIN TUBING | Abco Dealers, Inc. | 1982-06-16 | 8 | 0 |
| K803142 | CONPHAR VELCRO TOUNIGUER | Conphar, Inc. | 1981-01-13 | 32 | 0 |
| K790802 | ESSAR TOURNIQUET FOR VENIPUNCTURE | Stewart Research, Inc. | 1979-05-01 | 6 | 0 |
| K780594 | VELKET TOURNIQUET | Abco Dealers, Inc. | 1978-06-06 | 57 | 0 |
| K780429 | TOURNEQUET, NON-PNEUMATIC | Hemox, Inc. | 1978-04-18 | 32 | 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