510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K131026Substantially Equivalent

Bosch Blood Pressure Meter (Bp5000 Bt)

Robert Bosch Healthcare Systems, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131026 is the FDA 510(k) clearance record for BOSCH BLOOD PRESSURE METER (BP5000 BT), a class II device, cleared for Robert Bosch Healthcare Systems, Inc. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list one 510(k) clearance for Robert Bosch Healthcare Systems, Inc. As of , FDA records show no recalls naming K131026.

Clearance record

Decision date
Received
(216 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Robert Bosch Healthcare Systems, Inc. 2400 Geng Rd. Suite 200, Palo Alto CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261