510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K902977Substantially Equivalent

K3 Computer Systems

Donald L. King M.D., Darien CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902977 is the FDA 510(k) clearance record for K3 COMPUTER SYSTEMS, a class II device, cleared for Donald L. King M.D. on under FDA product code DPT (Probe, Blood-Flow, Extravascular). FDA records list one 510(k) clearance for Donald L. King M.D. As of , FDA records show no recalls naming K902977.

Clearance record

Decision date
Received
(662 days to decision)
Product code
DPT Probe, Blood-Flow, Extravascular
Regulation
21 CFR 870.2120
Device class
Class II
Review panel
Cardiovascular
Applicant
Donald L. King M.D. 19 Searles Rd., Darien CT
Third party review
No

Clearances, product code DPT

Trailing 12 months

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

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