Atlas FDA

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

Instranetics, Inc. — Predicate Candidate Screening

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

22 daysmedian FDA review time
81 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823430INSTRA-SAFEInstranetics, Inc.1983-01-07520
K811822TIP-VUInstranetics, Inc.1981-07-20210
K811823SHARPS CADDY FBInstranetics, Inc.1981-07-20210
K811824CAUTERY CADDY PADInstranetics, Inc.1981-07-20210
K810294LINE CADDYInstranetics, Inc.1981-02-26220
K810208BLADE SAFEInstranetics, Inc.1981-02-12170
K802865SAFE T COUNTInstranetics, Inc.1980-12-18360
K802866SHARPS CADDY MAGNETIC & SHARPS CADDY FOAInstranetics, Inc.1980-11-1750
K781575DISPOSABLE LYMPHANGIOGRAM SETInstranetics, Inc.1978-12-04810
K770894NEURO-SORB PATTIESInstranetics, Inc.1977-06-20350

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