Atlas FDA

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

Bio-Med USA, Inc. — Predicate Candidate Screening

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

156 daysmedian FDA review time
238 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.2022-08-09490
K212082PicoreBio-Med USA, Inc.2021-10-06960
K182270Cellene CO2 Laser SystemBio-Med USA, Inc.2018-11-02720
K163638Dental 5 Multi Diode laserBio-Med USA, Inc.2017-05-151430
K140837LUCID LYBio-Med USA, Inc.2014-09-241750
K133774ATOVENBio-Med USA, Inc.2014-06-061760
K123710UNITOX BOTOX SYRINGEBio-Med USA, Inc.2013-05-091560
K121268WANDY DISPERSVIE ELECTRODEBio-Med USA, Inc.2012-12-202380
K111831MX-7000 MICROXELBio-Med USA, Inc.2011-12-191740
K081547BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.2008-09-08980

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