Cleared Traditional

K946149 - STRYKER AGILITY INTENSIVE CARE BED

K946149 is an FDA 510(k) clearance for STRYKER AGILITY INTENSIVE CARE BED, manufactured by Stryker Medical. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K946149 · Stryker Medical · General Hospital
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Mar 1995
Decision
88d
Days
Class 2
Risk

K946149 is an FDA 510(k) clearance for the STRYKER AGILITY INTENSIVE CARE BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 88 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 Stryker Medical devices

FDA 510(k) Submission Details - K946149

510(k) Number K946149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1994
Decision Date March 14, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
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 K946149.
IBED WIRELESS WITH IBED AWARENESS
K103536 · Stryker Corporation · Dec 2010
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