Cleared Traditional

K960756 - LIFETECH CASSETTE

K960756 is an FDA 510(k) clearance for LIFETECH CASSETTE, manufactured by Lifetech Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K960756 · Lifetech Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
553d
Days
Class 2
Risk

K960756 is an FDA 510(k) clearance for the LIFETECH CASSETTE. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Lifetech Systems, Inc. (Fairfax, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 553 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 Lifetech Systems, Inc. devices

FDA 510(k) Submission Details - K960756

510(k) Number K960756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1996
Decision Date August 29, 1997
Days to Decision 553 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
438d slower than avg
Panel avg: 115d · This submission: 553d
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 11
Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K960756.
EPIFLO(R)
K120764 · Neogenix, LLC · Apr 2012
NUMOBAG
K981949 · Numotech, Inc. · Feb 1999
O2 BOOT
K971507 · Gwr Medical, Llp · Nov 1997
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
K963777 · Stephenson Industries, Inc. · Jul 1997
O2 CARE
K882461 · Ballard Medical Products · Nov 1988
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
K840817 · Hospitak, Inc. · Apr 1984