510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862596Substantially Equivalent

Dr-2C (Modification)

General Devices, Bergenfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862596 is the FDA 510(k) clearance record for DR-2C (MODIFICATION), a class I device, cleared for General Devices on under FDA product code DSF (Recorder, Paper Chart). FDA records list 13 510(k) clearances for General Devices, from to . As of , FDA records show no recalls naming K862596.

Clearance record

Decision date
Received
(91 days to decision)
Product code
DSF Recorder, Paper Chart
Regulation
21 CFR 870.2810
Device class
Class I
Review panel
Cardiovascular
Applicant
General Devices 86 Harriet Ave., Bergenfield NJ
Third party review
No

Clearances, product code DSF

Trailing 12 months

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

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