510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081035Substantially Equivalent

Aesculon C2, Aesculon Chf Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2

Osypka Medical GmbH, La Jolla CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081035 is the FDA 510(k) clearance record for AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2, a class II device, cleared for Osypka Medical, Inc. on under FDA product code DSB (Plethysmograph, Impedance). FDA records list 7 510(k) clearances for Osypka Medical, Inc., from to . As of , FDA records show no recalls naming K081035.

Clearance record

Decision date
Received
(49 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Osypka Medical, Inc. 7855 Ivanhoe Ave., Suite 226, La Jolla CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260