Atlas FDA

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

Perry, Div. — Predicate Candidate Screening

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

48 daysmedian FDA review time
63 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K851226I.V. START KITPerry, Div.1985-05-01360
K844610PERRY SUTURING SET W/ANESTHETICPerry, Div.1985-01-29630
K844609PERRY SUTURING SETPerry, Div.1985-01-15490
K844001LANCE BLADES & SCALPELSPerry, Div.1984-11-08270
K843125PERRY DERMAGUARD SURGICAL GLOVESPerry, Div.1984-09-25480
K833920KELLY CHOLANGIOCATHPerry, Div.1983-12-27430

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