Cleared Traditional

K970428 - REST X SYSTEM

K970428 is an FDA 510(k) clearance for REST X SYSTEM, manufactured by Restxsys. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K970428 · Restxsys · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
99d
Days
Class 2
Risk

K970428 is an FDA 510(k) clearance for the REST X SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Restxsys (Gaithersburg, US). The FDA issued a Cleared decision on May 14, 1997 after a review of 99 days - within the typical 510(k) review window.

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

View all Restxsys devices

FDA 510(k) Submission Details - K970428

510(k) Number K970428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date May 14, 1997
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 K970428.
MODIFIED PEDIKAIR
K954320 · Kinetic Concepts, Inc. · Jul 1997
REST MATTRESS
K971568 · Rest Mattress · Jul 1997
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
K970362 · Apex Metal, Inc. · May 1997
EQUI-PISE 1000 MRS
K970350 · Advanced Air Support Consultancy, Inc. · Apr 1997
PRESSUREGUARD: SELECTCARE
K960188 · Span-America Medical Systems, Inc. · Oct 1996
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854 · Gaymar Industries, Inc. · Aug 1996