510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854070Substantially Equivalent

Modification 7200 Microprocessor Ventilator System

Medtronic, Inc., Overland Park KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854070 is the FDA 510(k) clearance record for MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM, a class II device, cleared for Puritan Bennett Corp. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K854070.

Clearance record

Decision date
Received
(133 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 9401 Indian Creek Pkwy., Overland Park KS
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260