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

Pack, Hot Or Cold, Disposable

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

IMD is the FDA product code for Pack, Hot Or Cold, Disposable, a class I device type, regulated under 21 CFR 890.5710. As of , FDA records hold 82 510(k) clearances under this code, the most recent dated , and 26 recalls.

Classification record

Product code
IMD
Device name
Pack, Hot Or Cold, Disposable
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
82
Ingested recalls
26

Clearances, product code IMD

By decision year
82 clearances under product code IMD with a decision year between 1976 and 2022, 1996 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code IMD by decision year
YearClearances
19762
19772
19784
19793
19801
19815
19825
19841
19855
19862
19874
19882
19894
19905
19911
19921
19934
19946
19955
19969
19973
19981
19991
20021
20071
20081
20121
20171
20221

Applicants with the most clearances

Product code IMD
Applicants holding the most 510(k) clearances under product code IMD
ApplicantClearances
Omni Therm, Inc.4
Prism Technologies, Inc.4
Medtronic, Inc.3
Anago, Inc.3
Consolidated Products & Services, Inc.3
Signal West3
Baxter Healthcare Corporation2
Bio-Lipid, Inc.2
Certified Safety Mfg Inc2
Kick Ice, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 373 companies shown, in name order