510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933278Substantially Equivalent

Intermedics Triangle Chest Probe Model 526-04

Intermedics, Inc., Angleton TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933278 is the FDA 510(k) clearance record for INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04, a class III device, cleared for Intermedics, Inc. on under FDA product code KRG (Programmer, Pacemaker). FDA records list 211 510(k) clearances for Intermedics, Inc., from to . As of , FDA records show no recalls naming K933278.

Clearance record

Decision date
Received
(624 days to decision)
Product code
KRG Programmer, Pacemaker
Regulation
21 CFR 870.3700
Device class
Class III
Review panel
Cardiovascular
Applicant
Intermedics, Inc. 4000 Technology Dr., Angleton TX
510(k) summary
Summary
Third party review
No

Clearances, product code KRG

Trailing 12 months

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

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