Cleared Traditional

K030283 - BABY POD

K030283 is an FDA 510(k) clearance for BABY POD, manufactured by Prism Enterprises, Inc.. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K030283 · Prism Enterprises, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
85d
Days
Class 1
Risk

K030283 is an FDA 510(k) clearance for the BABY POD. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Prism Enterprises, Inc. (Stillwater, US). The FDA issued a Cleared decision on April 22, 2003 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6900 - 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 - K030283

510(k) Number K030283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date April 22, 2003
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

FPP Device Classification - Class 1, General Controls

Product Code FPP Stretcher, Hand-carried
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6900
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.

Regulatory Peers - FPP Stretcher, Hand-carried

All 36
Devices cleared under the same product code (FPP) and FDA review panel - the closest regulatory comparables to K030283.
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K030283 · BABY POD
Download PDF FDA Summary Prism Enterprises, In…