510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780365Substantially Equivalent

Oxygen/nitrous Oxide Outlet

Spica, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780365 is the FDA 510(k) clearance record for OXYGEN/NITROUS OXIDE OUTLET, a class I device, cleared for Spica, Inc. on under FDA product code CAM (Yoke Assembly, Medical Gas). FDA records list 3 510(k) clearances for Spica, Inc., from to . As of , FDA records show no recalls naming K780365.

Clearance record

Decision date
Received
(24 days to decision)
Product code
CAM Yoke Assembly, Medical Gas
Regulation
21 CFR 868.6885
Device class
Class I
Review panel
Anesthesiology
Applicant
Spica, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CAM

Trailing 12 months

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

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