510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050006Substantially Equivalent

Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio

C.R. Bard Inc, Lowell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050006 is the FDA 510(k) clearance record for BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DRQ (Amplifier And Signal Conditioner, Transducer Signal). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K050006.

Clearance record

Decision date
Received
(144 days to decision)
Product code
DRQ Amplifier And Signal Conditioner, Transducer Signal
Regulation
21 CFR 870.2060
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 55 Technology Dr., Lowell MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRQ

Trailing 12 months

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

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