510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202733Substantially Equivalent

Quantum Ventilation Module

Spectrum Medical Inc, Gloucester, GB / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202733 is the FDA 510(k) clearance record for Quantum Ventilation Module, a class II device, cleared for Spectrum Medical , Ltd. on under FDA product code DTX (Gas Control Unit, Cardiopulmonary Bypass). FDA records list 38 510(k) clearances for Spectrum Medical , Ltd., from to . As of , FDA records show no recalls naming K202733.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DTX Gas Control Unit, Cardiopulmonary Bypass
Regulation
21 CFR 870.4300
Device class
Class II
Review panel
Cardiovascular
Applicant
Spectrum Medical , Ltd. Harrier 4, Meteor Business Park, Cheltenham Rd. E., Gloucester, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTX

Trailing 12 months

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

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