Cleared Traditional

K974296 - MODEL 720 SERIES FULL/SEMI ELECTRIC BED...

K974296 is an FDA 510(k) clearance for MODEL 720 SERIES FULL/SEMI ELECTRIC BED..., manufactured by Invacare Corp.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K974296 · Invacare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
50d
Days
Class 2
Risk

K974296 is an FDA 510(k) clearance for the MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on January 6, 1998 after a review of 50 days - a notably fast clearance 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: 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 Invacare Corp. devices

FDA 510(k) Submission Details - K974296

510(k) Number K974296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date January 06, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 15
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K974296.
iBed Wireless with iBed Mobile
K202964 · Stryker Corporation · Jun 2021
IBED WIRELESS WITH IBED AWARENESS
K103536 · Stryker Corporation · Dec 2010
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