Atlas FDA

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

International Biophysics Corp. · Predicate Candidate Screening

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

172 daysmedian FDA review time
423 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K072688LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000International Biophysics Corp.2008-01-111090
K030181INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEMInternational Biophysics Corp.2003-04-17900
K992657IBC VRV, MODEL 1350International Biophysics Corp.2000-02-181930
K992785IBC FLOGUARD, MODEL 6050International Biophysics Corp.2000-01-141480
K992964IBC VENT VALVE, MODEL 1400International Biophysics Corp.1999-11-19780
K983272IBC FLOPUMP, MODEL 6000International Biophysics Corp.1999-03-241880
K963703ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)International Biophysics Corp.1998-04-085691
K963756IBC CARDIAC SUCTION WARDInternational Biophysics Corp.1997-11-144232
K963698CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4International Biophysics Corp.1997-03-201850
K955379IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)International Biophysics Corp.1996-05-141720
K955380IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)International Biophysics Corp.1996-05-141720

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