510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863825Substantially Equivalent

Co-Oximeter Solutions

D.R.G. Scientific Industries, East Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863825 is the FDA 510(k) clearance record for CO-OXIMETER SOLUTIONS, a class I device, cleared for D.R.G. Scientific Industries on under FDA product code JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide). FDA records list 5 510(k) clearances for D.R.G. Scientific Industries, from to . As of , FDA records show no recalls naming K863825.

Clearance record

Decision date
Received
(55 days to decision)
Product code
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Regulation
21 CFR 862.3220
Device class
Class I
Review panel
Clinical Toxicology
Applicant
D.R.G. Scientific Industries 1140 Saratoga St., East Boston MA
Third party review
No

Clearances, product code JKS

Trailing 12 months

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

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