510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K031128Substantially Equivalent

B-Smart, Model B-01

Macosta Medical USA, LLC, Ayer MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031128 is the FDA 510(k) clearance record for B-SMART, MODEL B-01, a class II device, cleared for Macosta Medical USA, LLC on under FDA product code CAZ (Anesthesia Conduction Kit). FDA's definition for product code CAZ reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the...". FDA records list one 510(k) clearance for Macosta Medical USA, LLC. As of , FDA records show no recalls naming K031128.

Clearance record

Decision date
Received
(281 days to decision)
Product code
CAZ Anesthesia Conduction Kit
Regulation
21 CFR 868.5140
Device class
Class II
Review panel
Anesthesiology
Applicant
Macosta Medical USA, LLC 5 Whitcomb Ave., Ayer MA
510(k) summary
Statement
Third party review
No

Clearances, product code CAZ

Trailing 12 months
1 clearance under product code CAZ in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAZ, 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 20261
October 20260