Cleared Traditional

K020219 - RPI SKIN OR AIR TEMPERATURE PROBE

K020219 is an FDA 510(k) clearance for RPI SKIN OR AIR TEMPERATURE PROBE, manufactured by Replacement Parts Industries, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K020219 · Replacement Parts Industries, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
80d
Days
Class 2
Risk

K020219 is an FDA 510(k) clearance for the RPI SKIN OR AIR TEMPERATURE PROBE. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Replacement Parts Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 12, 2002 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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 - K020219

510(k) Number K020219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date April 12, 2002
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMT Device Classification - Class 2, Special Controls

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
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 - FMT Warmer, Infant Radiant

All 90
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K020219.
V-505 INFA WARMER
K060461 · Atom Medical, Inc. · Apr 2006
PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
K033040 · International Hospital Supply Co. · Dec 2003
RPI REPLACEMENT HEATING ELEMENTS
K020966 · Replacement Parts Industries, Inc. · Jun 2002
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
K012229 · National Custom Ent., Inc. · Sep 2001
RESUSCITAIRE RADIANT WARMER
K003335 · Hill-Rom Air-Shields · Nov 2000
ATOM INFA WARMER V-505
K002355 · Atom Medical Corp · Oct 2000
K020219 · RPI SKIN OR AIR TEMPERATURE PROBE
Download PDF FDA Summary Replacement Parts Ind…