510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915312Substantially Equivalent

Modification Puritan Benett Companion 2801 Vol Ven

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

K915312 is the FDA 510(k) clearance record for MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN, 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 K915312.

Clearance record

Decision date
Received
(229 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
510(k) summary
Statement
Third party review
No

Clearances, product code CBK

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