Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GIO — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
60 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972969 | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM | Innovative Medical Technologies, Inc. | 1997-09-22 | 42 | 0 |
| K941291 | MONOJECT SAMPLETTE SEPARATOR TUBE | Sherwood Medical Co. | 1994-10-27 | 224 | 0 |
| K894851 | TRU-TRAX | Humagen, Inc. | 1989-09-29 | 60 | 0 |
| K885324 | HEMA(PRO)TEC(TION) | Medical Products Search, Inc. | 1989-02-17 | 51 | 0 |
| K885138 | CAPILLARY TUBE, BLOOD COLLECTION | Coeur Laboratories, Inc. | 1989-02-07 | 54 | 0 |
| K884623 | SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE | Safe-Tec Clinical Products, Inc. | 1988-12-01 | 27 | 0 |
| K881187 | NATELSON TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | 1988-05-06 | 46 | 0 |
| K881262 | CARAWAY TUBES, HEPARIN AND PLAIN | Helps Products, Inc. | 1988-05-06 | 43 | 0 |
| K875061 | MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR | Sherwood Medical Co. | 1988-01-12 | 34 | 0 |
| K873647 | VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE | Ventrex Laboratories, Inc. | 1987-10-20 | 41 | 0 |
| K850806 | CORNING BLOOD COLLECTION CAPILLARY TUBES | Corning Medical & Scientific | 1985-03-25 | 26 | 0 |
| K843608 | CAPILLARY BLOOD COLLECTION TUBE | Medical Technomics, Ltd. | 1984-11-30 | 78 | 0 |
| K843892 | MICRO HEMATOCRIT CAPILLARY TUBES | Abco Dealers, Inc. | 1984-11-13 | 41 | 0 |
| K843361 | MINICAPS | Medical Technomics, Ltd. | 1984-09-21 | 24 | 0 |
| K843362 | RINGCAPS | Medical Technomics, Ltd. | 1984-09-21 | 24 | 0 |
| K832578 | MONOJET SAMPLETTE ADAPTERS | Sherwood Medical Co. | 1983-08-31 | 29 | 0 |
| K812969 | S/P CAPILLARY TUBES, HEPARINIZED (2A) | American Dade | 1981-11-06 | 15 | 0 |
| K812921 | S/P SURE-CAP | American Dade | 1981-11-06 | 18 | 0 |
| K812923 | S/P SURE-CAP N | American Dade | 1981-11-06 | 18 | 0 |
| K812970 | S/P CAPILLARY TUBES, HEPARINIZED (3A) | American Dade | 1981-11-06 | 15 | 0 |
| K812922 | S/P SURE-CAP C | American Dade | 1981-11-06 | 18 | 0 |
| K770981 | LANCER CAPILLARY BLOOD SERUM SEPARATOR | Sherwood Medical Industries | 1977-07-11 | 41 | 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