510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992618Substantially Equivalent

Respalert

Harwill Medical (Pty), Ltd., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992618 is the FDA 510(k) clearance record for RESPALERT, a class II device, cleared for Harwill Medical (Pty) , Ltd. on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list 4 510(k) clearances for Harwill Medical (Pty) , Ltd., from to . As of , FDA records show no recalls naming K992618.

Clearance record

Decision date
Received
(86 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Harwill Medical (Pty) , Ltd. P.O. Box 4341, Crofton MD
510(k) summary
Statement
Third party review
No

Clearances, product code BZH

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