Cleared Traditional

K912237 - STRYKER ECLIPSE WARMING STRETCHER

K912237 is an FDA 510(k) clearance for STRYKER ECLIPSE WARMING STRETCHER, manufactured by Stryker Medical. The device is a Class 1 General & Plastic Surgery device with product code DWI cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K912237 · Stryker Medical · General & Plastic Surgery device
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Jul 1991
Decision
70d
Days
Class 1
Risk

K912237 is an FDA 510(k) clearance for the STRYKER ECLIPSE WARMING STRETCHER. Classified as Saw, Electrically Powered (product code DWI), Class I - General Controls.

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on July 30, 1991 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery 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 - K912237

510(k) Number K912237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date July 30, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

DWI Device Classification - Class 1, General Controls

Product Code DWI Saw, Electrically Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.