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

Regulator, Vacuum

21 CFR 880.6740 / General Hospital
FDA source (opens on fda.gov)

KDP is the FDA product code for Regulator, Vacuum, a class II device type, regulated under 21 CFR 880.6740. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
KDP
Device name
Regulator, Vacuum
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
21
Ingested recalls
4

Clearances, product code KDP

By decision year
21 clearances under product code KDP with a decision year between 1976 and 2002, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KDP by decision year
YearClearances
19762
19771
19801
19823
19832
19842
19852
19882
19932
19943
20021

Applicants with the most clearances

Product code KDP
Applicants holding the most 510(k) clearances under product code KDP
ApplicantClearances
Boehringer Laboratories, LLC4
Harris-Lake, Inc.2
Precision Medical, Inc.2
Sorensen Research2
American Hospital Supply1
Engineered Orthopedic Technologies, Inc.1
H.I. Silverman, D.Sc.1
Hill-Rom Inc.1
J. H. Emerson Co.1
Ohio Medical Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order