510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912596Substantially Equivalent

Meconium Aspiration

Pacific Device, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912596 is the FDA 510(k) clearance record for MECONIUM ASPIRATION, a class I device, cleared for Pacific Device, Inc. on under FDA product code BSY (Catheters, Suction, Tracheobronchial). FDA records list 5 510(k) clearances for Pacific Device, Inc., from to . As of , FDA records show no recalls naming K912596.

Clearance record

Decision date
Received
(50 days to decision)
Product code
BSY Catheters, Suction, Tracheobronchial
Regulation
21 CFR 868.6810
Device class
Class I
Review panel
Anesthesiology
Applicant
Pacific Device, Inc. 8572 Spectrum Ln., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code BSY

Trailing 12 months

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

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