510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K092903Substantially Equivalent

Bora Up 2080, Bora Up 2080 Op and Bora Up 2080 Mounting

Maquet GmbH and Co. KG, Rastatt De-Bw, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092903 is the FDA 510(k) clearance record for BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING, a class II device, cleared for Maquet GmbH and Co. KG on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list one 510(k) clearance for Maquet GmbH and Co. KG. As of , FDA records show no recalls naming K092903.

Clearance record

Decision date
Received
(71 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
Maquet GmbH and Co. KG Kehler Strasse 31, Rastatt De-Bw, DE
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BTA

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