Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Equi-Tron Mfg., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
85 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962763 | 2000 MODULAR THIRTY-NINE | Equi-Tron Mfg., Inc. | 1996-10-07 | 83 | 0 |
| K903904 | SERIES 2000 ADJUSTABLE BED | Equi-Tron Mfg., Inc. | 1990-10-12 | 50 | 0 |
| K903905 | SERIES 9000 LIFT-RECLINE CHAIR | Equi-Tron Mfg., Inc. | 1990-09-17 | 25 | 0 |
| K902089 | EQUI-GUARD (ASPIRATOR FILTER) | Equi-Tron Mfg., Inc. | 1990-07-06 | 58 | 0 |
| K894831 | PORTABLE AIR COMPRESSOR MODEL NUMBER 8125 | Equi-Tron Mfg., Inc. | 1989-10-24 | 85 | 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