Cleared Traditional

K960012 - STRYKER ADEL BASSINET

K960012 is an FDA 510(k) clearance for STRYKER ADEL BASSINET, manufactured by Stryker Corp.. The device is a Class 2 General Hospital device with product code FMS cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K960012 · Stryker Corp. · General Hospital
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Mar 1996
Decision
83d
Days
Class 2
Risk

K960012 is an FDA 510(k) clearance for the STRYKER ADEL BASSINET. Classified as Bed, Pediatric Open Hospital (product code FMS), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on March 25, 1996 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5140 - 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.

FDA 510(k) Submission Details - K960012

510(k) Number K960012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date March 25, 1996
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMS Device Classification - Class 2, Special Controls

Product Code FMS Bed, Pediatric Open Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5140
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 - FMS Bed, Pediatric Open Hospital

All 26
Devices cleared under the same product code (FMS) and FDA review panel - the closest regulatory comparables to K960012.
NATURE'S CRADLE
K970334 · Infant Advantage, Inc. · Apr 1997
VAIL 100 PEDIATRIC CRIB
K963210 · Vail Products, Inc. · Nov 1996
NATURE'S CRADLE MODEL C1500
K960747 · Infant Advantage, Inc. · May 1996
NATURE'S CRADLE
K951024 · Infant Advantage, Inc. · Jun 1995
BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B
K950051 · The Brewer Co. · Feb 1995
MC HEALTHCARE #CH31 CHILD'S CRIB
K950058 · Janco Consulting Services · Feb 1995
K960012 · STRYKER ADEL BASSINET
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