510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851460Substantially Equivalent

New Connector & Cover for Telectronics 8Mm Unipola

Telectronics, Inc., Suffield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851460 is the FDA 510(k) clearance record for NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA, a class I device, cleared for Telectronics, Inc. on under FDA product code BXY (Flowmeter, Calibration, Gas). FDA records list 107 510(k) clearances for Telectronics, Inc., from to . As of , FDA records show no recalls naming K851460.

Clearance record

Decision date
Received
(29 days to decision)
Product code
BXY Flowmeter, Calibration, Gas
Regulation
21 CFR 868.2350
Device class
Class I
Review panel
Anesthesiology
Applicant
Telectronics, Inc. 40 Crane Hill Rd., Suffield CT
Third party review
No

Clearances, product code BXY

Trailing 12 months

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

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