510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K042018Substantially Equivalent

Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-Up Pedi System

Simply Clean Air & Water, Inc., Newington CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042018 is the FDA 510(k) clearance record for ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM, a class II device, cleared for Simply Clean Air & Water, Inc. on under FDA product code FIP (Subsystem, Water Purification). FDA records list one 510(k) clearance for Simply Clean Air & Water, Inc. As of , FDA records show no recalls naming K042018.

Clearance record

Decision date
Received
(262 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Simply Clean Air & Water, Inc. 28 Shepard Dr., Newington CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FIP

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