Cleared Traditional

K202964 - iBed Wireless with iBed Mobile

K202964 is the FDA 510(k) clearance for iBed Wireless with iBed Mobile by Stryker Corporation. It is a Class 2 General Hospital device (product code FNL) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K202964 · Stryker Corporation · General Hospital
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Jun 2021
Decision
261d
Days
Class 2
Risk

K202964 is an FDA 510(k) clearance for the iBed Wireless with iBed Mobile. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Stryker Corporation (Portage, US). The FDA issued a Cleared decision on June 18, 2021 after a review of 261 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 Stryker Corporation devices

Submission Details

510(k) Number K202964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date June 18, 2021
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K202964.
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
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