Atlas FDA

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

O-Two Systems Intl., Inc. — Predicate Candidate Screening

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

64 daysmedian FDA review time
301 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991195CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, ANO-Two Systems Intl., Inc.1999-04-22140
K983857AUTOVENT 1500O-Two Systems Intl., Inc.1998-11-0420
K983785AUTOVENT 1000O-Two Systems Intl., Inc.1998-10-2920
K983643GENESIS BLSO-Two Systems Intl., Inc.1998-10-29130
K983705EMT RESUSCITATORO-Two Systems Intl., Inc.1998-10-2980
K960995CPR BIO-BARRIER FACESHEILDO-Two Systems Intl., Inc.1997-01-073010
K940712PPM IIIO-Two Systems Intl., Inc.1994-11-142700
K940927RESCUE BREATHERO-Two Systems Intl., Inc.1994-10-142280
K932170FLYNNR GENESIS II A/C, A/O AND IDLHO-Two Systems Intl., Inc.1993-10-251740
K922810ODYSSEYO-Two Systems Intl., Inc.1993-01-222260
K913039FLLYNN(R) GENESIS ACO-Two Systems Intl., Inc.1992-08-254130
K841429MOUTH TO MASK EMERGENCY VENTILATIONO-Two Systems Intl., Inc.1984-04-17110
K834400FLYNN III-CHILD BAG-MASK UNIT ETCO-Two Systems Intl., Inc.1984-01-13300
K832495FLYNN SERIES III BAG/MASK UNIT-O-Two Systems Intl., Inc.1983-09-29640

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