510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K953458Unknown

Rainbow Step Up Systems Inc. Asthma Home Care Plan

Raiinbow Step UP Systems, Inc., North Andover MA / Traditional, Unknown
FDA source (opens on fda.gov)

K953458 is the FDA 510(k) clearance record for RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN, a class II device, cleared for Raiinbow Step UP Systems, Inc. on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list one 510(k) clearance for Raiinbow Step UP Systems, Inc. As of , FDA records show no recalls naming K953458.

Clearance record

Decision date
Received
(119 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Raiinbow Step UP Systems, Inc. 555 Tpke. St., North Andover MA
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