510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MPOClass I

Infant Heel Warmer (Chemical Heat Pack)

21 CFR 890.5710 / Physical Medicine
FDA source (opens on fda.gov)

MPO is the FDA product code for Infant Heel Warmer (Chemical Heat Pack), a class I device type, regulated under 21 CFR 890.5710. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
MPO
Device name
Infant Heel Warmer (Chemical Heat Pack)
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
11
Ingested recalls
7

Clearances, product code MPO

By decision year
11 clearances under product code MPO with a decision year between 1996 and 2022, 1996 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MPO by decision year
YearClearances
19962
19971
20031
20042
20061
20111
20151
20161
20221

Applicants with the most clearances

Product code MPO
Applicants holding the most 510(k) clearances under product code MPO
ApplicantClearances
Rapid Aid Corp.2
Baxter Healthcare Corporation1
CooperSurgical, Inc.1
Debusk Knitting Mills, Div. Deroyal Industries1
Denovo Products, LLC1
Florida Medical Industries, Inc.1
International Biomedical, Ltd.1
Mediheat, Inc.1
Respironics, Inc.1
Shanghai Intco Medical Supply Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order