Cleared Traditional

K970350 - EQUI-PISE 1000 MRS

K970350 is an FDA 510(k) clearance for EQUI-PISE 1000 MRS, manufactured by Advanced Air Support Consultancy, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K970350 · Advanced Air Support Consultancy, Inc. · General Hospital
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Apr 1997
Decision
82d
Days
Class 2
Risk

K970350 is an FDA 510(k) clearance for the EQUI-PISE 1000 MRS. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Advanced Air Support Consultancy, Inc. (Hesperia, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5550 - the FDA general hospital 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.

View all Advanced Air Support Consultancy, Inc. devices

FDA 510(k) Submission Details - K970350

510(k) Number K970350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1997
Decision Date April 22, 1997
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNM Device Classification - Class 2, Special Controls

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
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 Hospital devices follow this clearance model.

Regulatory Peers - FNM Mattress, Air Flotation, Alternating Pressure

All 40
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K970350.
REST MATTRESS
K971568 · Rest Mattress · Jul 1997
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
K970362 · Apex Metal, Inc. · May 1997
REST X SYSTEM
K970428 · Restxsys · May 1997
PRESSUREGUARD: SELECTCARE
K960188 · Span-America Medical Systems, Inc. · Oct 1996
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854 · Gaymar Industries, Inc. · Aug 1996
POWERED LOW AIR LOSS MATTRESS SYSTEM
K961159 · Span-America Medical Systems, Inc. · Jun 1996