Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nestor Engineering Associates, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
111 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K780991 | PARALLEL BLADE MARKER | Nestor Engineering Associates, Inc. | 1978-10-03 | 111 | 0 |
| K780989 | DEVIN-NESTOR SQUARE KNIFE | Nestor Engineering Associates, Inc. | 1978-10-03 | 111 | 0 |
| K780990 | STAINLESS STEEL TEMPLATE | Nestor Engineering Associates, Inc. | 1978-10-03 | 111 | 0 |
| K780988 | DEVIN-NESTOR PNEUMATIC TOURNIQUET | Nestor Engineering Associates, Inc. | 1978-10-03 | 111 | 0 |
| K780992 | MILLARD MOUTH GAG | Nestor Engineering Associates, Inc. | 1978-08-17 | 64 | 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