Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gelman Instrument Co. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
92 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K772075 | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | Gelman Instrument Co. | 1978-02-03 | 92 | 0 |
| K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. | Gelman Instrument Co. | 1978-02-03 | 92 | 0 |
| K772077 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G | Gelman Instrument Co. | 1978-02-03 | 92 | 0 |
| K772079 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M | Gelman Instrument Co. | 1978-02-03 | 92 | 0 |
| K772073 | RADIAL IMMUNODIFFUSION KIT-COMP. 3 | Gelman Instrument Co. | 1978-02-03 | 92 | 0 |
| K772074 | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN | Gelman Instrument Co. | 1978-02-03 | 92 | 0 |
| K772078 | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | Gelman Instrument Co. | 1978-02-03 | 92 | 0 |
| K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT | Gelman Instrument Co. | 1978-02-03 | 92 | 0 |
| K772325 | DENSITOMETER 18, COMPUTING, AUTO. | Gelman Instrument Co. | 1978-01-12 | 24 | 0 |
| K771812 | LIPPOPROTEIN ELECTROPHORESIS REAGENT SET | Gelman Instrument Co. | 1977-10-18 | 21 | 0 |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | Gelman Instrument Co. | 1977-01-31 | 7 | 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