Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eder Instrument Co, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
147 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843498 | BIPOLAR SUCTION ELECTRODE | Eder Instrument Co, Inc. | 1984-12-14 | 99 | 0 |
| K843497 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1984-10-31 | 55 | 0 |
| K843499 | ARTHROSCOPY LEG HOLDER | Eder Instrument Co, Inc. | 1984-10-31 | 55 | 0 |
| K831255 | LARYNGOSCOPE ATTACHMENT PH2000 | Eder Instrument Co, Inc. | 1983-09-12 | 147 | 0 |
| K831240 | LASER BRONCHOSCOPE | Eder Instrument Co, Inc. | 1983-07-26 | 102 | 0 |
| K831241 | LASER LAPARAXOPE | Eder Instrument Co, Inc. | 1983-06-10 | 56 | 0 |
| K822959 | ENDOSCOPIC VIDEOSYSTEM | Eder Instrument Co, Inc. | 1982-10-22 | 17 | 0 |
| K802479 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1980-10-31 | 24 | 0 |
| K792100 | GRASPING FORCEP (W/FOUR PRONGS) | Eder Instrument Co, Inc. | 1979-11-13 | 25 | 0 |
| K791052 | ENDOSCOPIC INSTRUMENT | Eder Instrument Co, Inc. | 1979-08-03 | 58 | 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