510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K972086Substantially Equivalent

Alexander Manufacturing Co. Rechargeable Battery Part Number Ms311

Alexander Mfg. Co., Mason City IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972086 is the FDA 510(k) clearance record for ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311, a class II device, cleared for Alexander Mfg. Co. on under FDA product code BZK (Spirometer, Monitoring (W/Wo Alarm)). FDA records list 39 510(k) clearances for Alexander Mfg. Co., from to . As of , FDA records show no recalls naming K972086.

Clearance record

Decision date
Received
(69 days to decision)
Product code
BZK Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
Device class
Class II
Review panel
Anesthesiology
Applicant
Alexander Mfg. Co. 1511 S Garfield Pl., Mason City IA
510(k) summary
Statement
Third party review
No

Clearances, product code BZK

Trailing 12 months
1 clearance under product code BZK 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 BZK, 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