Atlas FDA

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

Prowess, Inc. — Predicate Candidate Screening

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

116 daysmedian FDA review time
365 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231825Panther TPSProwess, Inc.2023-12-151770
K211760Panther OISProwess, Inc.2021-09-281120
K193459Panther StereotacticProwess, Inc.2020-04-271330
K143514Panther StereoSeedProwess, Inc.2015-12-113650
K122616PANTHER OIS/R & V MODEL VERSION 2.0Prowess, Inc.2012-12-211160
K101076PROWESS PANTHER PROARC, MODEL VERSION 5.0Prowess, Inc.2010-07-27990
K100801PUMA MODEL VERSION 1.0Prowess, Inc.2010-06-18880
K083502PANTHER REALART, MODEL 4.7Prowess, Inc.2009-05-051610
K032456PROWESSProwess, Inc.2003-10-16660

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