510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872230Substantially Equivalent

Model 366-29 Adaptaid(tm) Adapter Sleeve

Intermedics, Inc., Freeport TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872230 is the FDA 510(k) clearance record for MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE, a class I device, cleared for Intermedics, Inc. on under FDA product code DBT (Factor Xiii A, S, Antigen, Antiserum, Control). FDA records list 211 510(k) clearances for Intermedics, Inc., from to . As of , FDA records show no recalls naming K872230.

Clearance record

Decision date
Received
(98 days to decision)
Product code
DBT Factor Xiii A, S, Antigen, Antiserum, Control
Regulation
21 CFR 866.5330
Device class
Class I
Review panel
Immunology
Applicant
Intermedics, Inc. P.O. Box 617, Freeport TX
Third party review
No

Clearances, product code DBT

Trailing 12 months

FDA records hold no clearances under product code DBT in the trailing twelve months.

FDA records show no clearances under product code DBT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DBT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260