510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K930549Substantially Equivalent

Laerdal Alternative Power, 5-6 A,5-6 B,2000

Rustronics, Inc., Pt. St. Lucie FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930549 is the FDA 510(k) clearance record for LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000, a class II device, cleared for Rustronics, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list one 510(k) clearance for Rustronics, Inc. As of , FDA records show no recalls naming K930549.

Clearance record

Decision date
Received
(135 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
Rustronics, Inc. 1587s. Niemeyer Cr., Pt. St. Lucie FL
510(k) summary
Statement
Third party review
No

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