510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K122756Substantially Equivalent

Penumbra Pump Max (110Vac), Penumbra Pump Max (230Vac), Penumbar Pump Max Canister/tubing

Penumbra Inc., Alameda CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122756 is the FDA 510(k) clearance record for PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING, a class II device, cleared for Penumbra, Inc. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list 87 510(k) clearances for Penumbra, Inc., from to . As of , FDA records show no recalls naming K122756.

Clearance record

Decision date
Received
(25 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Penumbra, Inc. 1351 Harbor Bay Pkwy., Alameda CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JCX

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