510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991003Substantially Equivalent

Pump Segment Rinse Line W/ Slip-on Connector, Pump Segment Rinse Line W/ Luer-Lock Connector, T-Connector, Short, W/ Sli

Dayspring Medical, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991003 is the FDA 510(k) clearance record for PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI, a class II device, cleared for Dayspring Medical, Inc. on under FDA product code FKY (Connector, Tubing, Dialysate). FDA records list 5 510(k) clearances for Dayspring Medical, Inc., from to . As of , FDA records show no recalls naming K991003.

Clearance record

Decision date
Received
(76 days to decision)
Product code
FKY Connector, Tubing, Dialysate
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dayspring Medical, Inc. 1936 Beacon Ct., Boulder CO
510(k) summary
Statement
Third party review
No

Clearances, product code FKY

Trailing 12 months

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

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