510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080621Substantially Equivalent

Fastlock, Model Pc175m01, Pc175mce, Pc005r01

Alto Development Corp, Claremont NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080621 is the FDA 510(k) clearance record for FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01, a class II device, cleared for European Custom Manufacturing BV on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list 12 510(k) clearances for ALTO DEVELOPMENT CORP., from to . As of , FDA records show no recalls naming K080621.

Clearance record

Decision date
Received
(55 days to decision)
Product code
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation
21 CFR 870.2900
Device class
Class II
Review panel
Cardiovascular
Applicant
European Custom Manufacturing BV 220 River Rd., Claremont NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSA

Trailing 12 months
2 clearances under product code DSA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260