Cleared Traditional

K883591 - MARK-5 CONCENTRATOR

K883591 is an FDA 510(k) clearance for MARK-5 CONCENTRATOR, manufactured by Nidek Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K883591 · Nidek Medical Products, Inc. · Anesthesiology device
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Nov 1988
Decision
71d
Days
Class 2
Risk

K883591 is an FDA 510(k) clearance for the MARK-5 CONCENTRATOR. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on November 2, 1988 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K883591

510(k) Number K883591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date November 02, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 286
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K883591.
RELIANT OXYGEN CONCENTRATOR
K884581 · Airsep Corp. · Jan 1989
MIKADO AC 405
K883837 · Ivex Medical, Inc. · Dec 1988
PORTABLE OXYGEN GENERATOR
K884084 · Mountain Medical Equipment, Inc. · Nov 1988
ALPINE PORTABLE OXYGEN GENERATOR
K881802 · Mountain Medical Equipment, Inc. · Jul 1988
OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8
K880044 · Oxygen Enrichment Company, Ltd. · Mar 1988
PALL FIELD MEDICAL OXYGEN GENERA. & DISTRI. SYSTEM
K873526 · Pall Safety Atmospheres, Inc. · Feb 1988
K883591 · MARK-5 CONCENTRATOR
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