510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K051758Substantially Equivalent

Penumbra Aspiration Pump, Model 115V

Penumbra Inc., San Leandro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051758 is the FDA 510(k) clearance record for PENUMBRA ASPIRATION PUMP, MODEL 115V, a class II device, cleared for Penumbra, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list 87 510(k) clearances for Penumbra, Inc., from to . As of , FDA records show no recalls naming K051758.

Clearance record

Decision date
Received
(49 days to decision)
Product code
BTA Pump, Portable, Aspiration (Manual Or Powered)
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Penumbra, Inc. 2401 Merced St., San Leandro CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTA

Trailing 12 months
7 clearances under product code BTA in the twelve months to November 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code BTA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20261
May 20264
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260