510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891927Substantially Equivalent

Telemetry Power Pack Model 2

Lucas & Rhea Mfg., Lavinia TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891927 is the FDA 510(k) clearance record for TELEMETRY POWER PACK MODEL 2, a class I device, cleared for Lucas & Rhea Mfg. on under FDA product code FCP (Box, Battery, Pocket). FDA records list one 510(k) clearance for Lucas & Rhea Mfg. As of , FDA records show no recalls naming K891927.

Clearance record

Decision date
Received
(394 days to decision)
Product code
FCP Box, Battery, Pocket
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Lucas & Rhea Mfg. Rte. 1, Box 12a, Lavinia TN
Third party review
No

Clearances, product code FCP

Trailing 12 months

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

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