Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gelman Sciences, Inc. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
159 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946190 | DRUG DISPENSING SPIKE | Gelman Sciences, Inc. | 1995-03-17 | 87 | 0 |
| K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | Gelman Sciences, Inc. | 1994-09-29 | 92 | 0 |
| K941589 | SYRINGE FILTER DEVICES | Gelman Sciences, Inc. | 1994-09-06 | 159 | 0 |
| K941020 | DRUG RECONSTITUTION FILTER DEVICE | Gelman Sciences, Inc. | 1994-08-10 | 160 | 0 |
| K942275 | VIAL VENT FILTER | Gelman Sciences, Inc. | 1994-07-26 | 77 | 0 |
| K941032 | UNKNOWN | Gelman Sciences, Inc. | 1994-05-27 | 81 | 0 |
| K910821 | TRANSDUCER PROTECTOR | Gelman Sciences, Inc. | 1991-08-12 | 167 | 0 |
| K892387 | MODIFIED GELMAN ARTERIAL FILTER | Gelman Sciences, Inc. | 1989-06-22 | 69 | 0 |
| K884176 | CHROMATOGRAPHY KIT | Gelman Sciences, Inc. | 1989-04-04 | 182 | 0 |
| K884178 | DRUG CONTROL SET | Gelman Sciences, Inc. | 1989-02-17 | 136 | 0 |
| K884177 | DRUG STANDARD SET | Gelman Sciences, Inc. | 1989-02-17 | 136 | 0 |
| K862068 | GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) | Gelman Sciences, Inc. | 1986-08-08 | 70 | 0 |
| K850260 | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER | Gelman Sciences, Inc. | 1985-02-27 | 36 | 0 |
| K850202 | GELMAN TRIPHOR CONTROL | Gelman Sciences, Inc. | 1985-02-06 | 19 | 0 |
| K842052 | GIARDIA GUARD | Gelman Sciences, Inc. | 1984-09-11 | 112 | 0 |
| K842560 | OPTIPHOR-10 | Gelman Sciences, Inc. | 1984-08-10 | 39 | 0 |
| K842485 | OPTICLEAR | Gelman Sciences, Inc. | 1984-08-10 | 46 | 0 |
| K823550 | CK-ISOZYME U.V. REAGENT SET | Gelman Sciences, Inc. | 1983-01-07 | 38 | 0 |
| K822121 | ACRO PACK | Gelman Sciences, Inc. | 1982-08-05 | 17 | 0 |
| K821303 | HI-PHORE HIGH RESOLUTION ELECTROPHORES | Gelman Sciences, Inc. | 1982-05-12 | 8 | 0 |
| K820518 | GELMAN GLYCO-PHORE BUFFER | Gelman Sciences, Inc. | 1982-04-09 | 43 | 0 |
| K813159 | VACUSHIELD TM | Gelman Sciences, Inc. | 1981-12-08 | 22 | 0 |
| K812539 | PRE-BYPASS FILTER | Gelman Sciences, Inc. | 1981-10-13 | 40 | 0 |
| K812253 | GELMAN IG-FIX KIT | Gelman Sciences, Inc. | 1981-09-01 | 21 | 0 |
| K811100 | GELMAN ELECTROPHORESIS CONTROL | Gelman Sciences, Inc. | 1981-05-01 | 9 | 0 |
| K810829 | ACRODISC | Gelman Sciences, Inc. | 1981-04-08 | 14 | 0 |
| K810047 | AUTOPHOR 128 | Gelman Sciences, Inc. | 1981-02-05 | 24 | 0 |
| K802765 | ACRODISC FILTER ASSEMBLY | Gelman Sciences, Inc. | 1981-01-21 | 78 | 0 |
| K801378 | HIPP BUFFER(NON-BARBITAL), P/N | Gelman Sciences, Inc. | 1980-07-14 | 33 | 0 |
| K791606 | GELMAN LIPOPROTEIN FRS SET. P/N 51213 | Gelman Sciences, Inc. | 1979-09-17 | 28 | 0 |
| K791111 | AUTOMATED ELECTROPHORESES MACHINE | Gelman Sciences, Inc. | 1979-07-30 | 46 | 0 |
| K790791 | ELECTROPHORESIS REAGENT SET, HDL | Gelman Sciences, Inc. | 1979-06-15 | 52 | 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