510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983468Substantially Equivalent

Fasttake Adapter, Model # P/n 020-072-01

Selfcare, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983468 is the FDA 510(k) clearance record for FASTTAKE ADAPTER, MODEL # P/N 020-072-01, a class I device, cleared for Selfcare, Inc. on under FDA product code JQP (Calculator/Data Processing Module, For Clinical Use). FDA records list 15 510(k) clearances for Selfcare, Inc., from to . As of , FDA records show no recalls naming K983468.

Clearance record

Decision date
Received
(77 days to decision)
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Regulation
21 CFR 862.2100
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Selfcare, Inc. 200 Prospect St., Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code JQP

Trailing 12 months

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

FDA records show no clearances under product code JQP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JQP, 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