510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062801Substantially Equivalent

Smartsuction Solo Device

Haemonetics Corporation, Braintree MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062801 is the FDA 510(k) clearance record for SMARTSUCTION SOLO DEVICE, a class II device, cleared for Haemonetics Corp. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list 36 510(k) clearances for Haemonetics Corp., from to . As of , FDA records show no recalls naming K062801.

Clearance record

Decision date
Received
(15 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
Haemonetics Corp. 400 Wood Rd., Braintree MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BTA

Trailing 12 months
6 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 20260