Cleared Traditional

K935837 - AIRHYTHM HEALTHCARE BED

K935837 is an FDA 510(k) clearance for AIRHYTHM HEALTHCARE BED, manufactured by Healthcare Designs. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K935837 · Healthcare Designs · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
196d
Days
Class 2
Risk

K935837 is an FDA 510(k) clearance for the AIRHYTHM HEALTHCARE BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Healthcare Designs (Saginaw, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 196 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5100 - 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 Healthcare Designs devices

FDA 510(k) Submission Details - K935837

510(k) Number K935837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1993
Decision Date June 21, 1994
Days to Decision 196 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 129d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNL Device Classification - Class 2, Special Controls

Product Code FNL Bed, Ac-powered Adjustable Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
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 - FNL Bed, Ac-powered Adjustable Hospital

All 16
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K935837.
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
K974296 · Invacare Corp. · Jan 1998
TOTALCARE
K962942 · Hill-Rom, Inc. · Feb 1997
BARIKARE PLUS
K945664 · Kinetic Concepts, Inc. · Feb 1995
MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES
K932663 · Medline Industries, Inc. · Nov 1993
GLENN BED
K931581 · Kinetic Concepts, Inc. · Oct 1993
STRYKER MPS ACUTE CARE BED
K931482 · Stryker Corp. · Sep 1993