Cleared Traditional

K981949 - NUMOBAG

K981949 is an FDA 510(k) clearance for NUMOBAG, manufactured by Numotech, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K981949 · Numotech, Inc. · General & Plastic Surgery device
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Feb 1999
Decision
245d
Days
Class 2
Risk

K981949 is an FDA 510(k) clearance for the NUMOBAG. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Numotech, Inc. (Woodland Hills, US). The FDA issued a Cleared decision on February 3, 1999 after a review of 245 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K981949

510(k) Number K981949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1998
Decision Date February 03, 1999
Days to Decision 245 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 115d · This submission: 245d
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 22
Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K981949.
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
K022028 · Vascular One, Inc. · Dec 2002
HEC 1000
K020466 · Metro Medical Equipment, Inc. · May 2002
OXYGENATOR
K002632 · Adjunctive Therapeutics, Inc. · Oct 2001
O2 BOOT
K971507 · Gwr Medical, Llp · Nov 1997
LIFETECH CASSETTE
K960756 · Lifetech Systems, Inc. · Aug 1997
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
K963777 · Stephenson Industries, Inc. · Jul 1997
K981949 · NUMOBAG
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