Cleared Traditional

K002632 - OXYGENATOR

K002632 is an FDA 510(k) clearance for OXYGENATOR, manufactured by Adjunctive Therapeutics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K002632 · Adjunctive Therapeutics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
428d
Days
Class 2
Risk

K002632 is an FDA 510(k) clearance for the OXYGENATOR. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Adjunctive Therapeutics, Inc. (Potomac, US). The FDA issued a Cleared decision on October 25, 2001 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5650 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Adjunctive Therapeutics, Inc. devices

FDA 510(k) Submission Details - K002632

510(k) Number K002632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2000
Decision Date October 25, 2001
Days to Decision 428 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 115d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPJ Device Classification - Class 2, Special Controls

Product Code KPJ Chamber, Oxygen, Topical, Extremity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KPJ Chamber, Oxygen, Topical, Extremity

All 12
Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K002632.
EPIFLO-28
K190742 · Neogenix, LLC Dba Ogenix · Dec 2019
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
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EPIFLO(R)
K120764 · Neogenix, LLC · Apr 2012
NUMOBAG
K981949 · Numotech, Inc. · Feb 1999
O2 BOOT
K971507 · Gwr Medical, Llp · Nov 1997
LIFETECH CASSETTE
K960756 · Lifetech Systems, Inc. · Aug 1997