Atlas FDA

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

Inamed Development Co. — Predicate Candidate Screening

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

102 daysmedian FDA review time
287 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K931548INAMED DEVELOPMENT ASPIRATION TIPInamed Development Co.1994-01-102870
K904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERInamed Development Co.1991-03-061690
K901742INAMED SMALL DRAIN SYSTEMInamed Development Co.1990-05-07200
K901764INAMED CONVERTIBLE DRAIN SYSTEMInamed Development Co.1990-05-07190
K894618INAMED RHEMO-D (TM) DILATORInamed Development Co.1990-01-181820
K896491INAMED CLOSED-WOUND DRAIN SYSTEMInamed Development Co.1990-01-08560
K894073INAMED PRO-TEC SILICONE SURGICAL GLOVESInamed Development Co.1989-09-181020

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