510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991378Substantially Equivalent

Phosphate Buffered Saline (Pbs), Phosphate Buffered Saline with Calcium, Magnesium, Glucose, Pyruvate and Phenol Red

Sage Biopharma, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991378 is the FDA 510(k) clearance record for PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED, a class II device, cleared for Sage Biopharma on under FDA product code MQL (Media, Reproductive). FDA records list 6 510(k) clearances for Sage Biopharma, from to . As of , FDA records show no recalls naming K991378.

Clearance record

Decision date
Received
(156 days to decision)
Product code
MQL Media, Reproductive
Regulation
21 CFR 884.6180
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sage Biopharma 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code MQL

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