510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954442Substantially Equivalent

Sterile Isotonic Saline & Sterile Water

Medcare Custom Packaging, Inc., East Swanzey NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954442 is the FDA 510(k) clearance record for STERILE ISOTONIC SALINE & STERILE WATER, a class II device, cleared for Medcare Custom Packaging, Inc. on under FDA product code JOL (Catheter And Tip, Suction). FDA records list 11 510(k) clearances for Medcare Custom Packaging, Inc., from to . As of , FDA records show no recalls naming K954442.

Clearance record

Decision date
Received
(87 days to decision)
Product code
JOL Catheter And Tip, Suction
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Medcare Custom Packaging, Inc. 234 Old Homestead Hwy., East Swanzey NH
510(k) summary
Summary
Third party review
No

Clearances, product code JOL

Trailing 12 months

FDA records hold no clearances under product code JOL in the trailing twelve months.

FDA records show no clearances under product code JOL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOL, 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 20260
October 20260