Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Engineering, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
125 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881521 | MODIFIED SERVO SYRINGE | Engineering, Inc. | 1988-05-31 | 53 | 0 |
| K862749 | LS9000 SUCTION BIOPSY NEEDLE | Engineering, Inc. | 1986-09-15 | 56 | 0 |
| K862476 | LS3000 CANNULA UTERINE SUCTION | Engineering, Inc. | 1986-07-18 | 18 | 0 |
| K854359 | LM2000A SURGICAL SUCTION MONITOR | Engineering, Inc. | 1986-03-03 | 125 | 0 |
| K854844 | LS1000 SURGICAL ASPIRATOR II | Engineering, Inc. | 1986-02-12 | 70 | 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