FDA applicant

International Biophysics Corp.

Austin, TX14 decisions1996–20214 recalls

FDA records 14 decisions for International Biophysics Corp. (Austin, TX) from 1996 to 2021: 14 510(k) clearances. Most are in product codes KFM (Pump, Blood, Cardiopulmonary Bypass…) and DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary…). Its devices cite 10 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “International Biophysics Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided International Biophysics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — International Biophysics Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like International Biophysics Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type3decisions
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2decisions
GEXPowered Laser Surgical Instrument1decision
MJJCpb Check Valve, Retrograde Flow, In-Line1decision
DWDSuction Control, Intracardiac, Cardiopulmonary Bypass1decision
DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass1decision

Also: BYI (1), DTY (1), MNJ (1), DPT (1), CAW (1).

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

K983272Ibc Flopump, Model 6000International Biophysics Corp. · 19992cite it
K122480International Biophysics Corporation AfflovestInternational Biophysics Corporation · 20132cite it
K963698CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4International Biophysics Corp. · 19972cite it
K072688Lifechoice Oxygen Concentrator, Model OXY1000International Biophysics Corp. · 20082cite it
K963756Ibc Cardiac Suction WardInternational Biophysics Corp. · 19971cites it
K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation · 20171cites it

What has FDA decided for it lately?

K193663FloPump 57mL Centrifugal PumpInternational Biophysics Corporation · 2021
K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation · 20171 recall
K122480International Biophysics Corporation AfflovestInternational Biophysics Corporation · 2013
K072688Lifechoice Oxygen Concentrator, Model OXY1000International Biophysics Corp. · 2008
K030181International Biophysics Corporation (Ibc) Laser Peel SystemInternational Biophysics Corp. · 2003
K992657Ibc VRV, Model 1350International Biophysics Corp. · 2000
K992785Ibc Floguard, Model 6050International Biophysics Corp. · 2000
K992964Ibc Vent Valve, Model 1400International Biophysics Corp. · 1999

All 11 as International Biophysics Corp. →All 3 as International Biophysics Corporation →

What has been recalled?

4 recalls linked to its devices; the latest:

K1700293/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx OnlyJun 24, 2019Class II
K963756IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component…Aug 7, 2015Class II
K963756IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744…Oct 5, 2011
K963703IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the…Apr 22, 2005