Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nobles-Lai Engineering, Inc. — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

157 daysmedian FDA review time
228 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K953554NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIESNobles-Lai Engineering, Inc.1995-10-18820
K933345NOBLES-LAI ENDOSCOPIC/LAPAROSCOPICNobles-Lai Engineering, Inc.1994-02-222280
K920026NOBLES-LAI IMAGING SYSTEMNobles-Lai Engineering, Inc.1992-07-282070
K914457DISPOSABLE OPTICAL VALVULOTOMENobles-Lai Engineering, Inc.1992-02-051210
K895688NOBLES-LAI ENGINEERING INFUSION PUMPNobles-Lai Engineering, Inc.1990-02-261570

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