510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011238Substantially Equivalent

Roda (Real Time Oxygen Dynamics Analysis) Monitoring System

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

K011238 is the FDA 510(k) clearance record for RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM, a class II device, cleared for Metracor Technologies, Inc. on under FDA product code LZF (Pump, Infusion, Analytical Sampling). FDA records list one 510(k) clearance for Metracor Technologies, Inc. As of , FDA records show no recalls naming K011238.

Clearance record

Decision date
Received
(260 days to decision)
Product code
LZF Pump, Infusion, Analytical Sampling
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Metracor Technologies, Inc. 11425 Sorrento Valley Rd., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code LZF

Trailing 12 months

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

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