510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K981905Substantially Equivalent

Sterile Saline Solution 0.9%- Catalog No, 10290, Sterile Water- Catalog No. 10291

Acu-Pak, Londonderry NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981905 is the FDA 510(k) clearance record for STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291, a class II device, cleared for Acu-Pak on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list one 510(k) clearance for Acu-Pak. As of , FDA records show no recalls naming K981905.

Clearance record

Decision date
Received
(78 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Acu-Pak 2 Perimeter Rd., E., Londonderry NH
510(k) summary
Summary
Third party review
No

Clearances, product code FOZ

Trailing 12 months
9 clearances under product code FOZ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260