Apheresis Technologies, Inc.

FDA Regulatory Profile

Apheresis Technologies, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2149-2012, Class II) was initiated on Jul 9, 2012. Its most recent FDA inspection ended on Jul 13, 2012 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Jun 14, 1996.

Reviewing Apheresis Technologies, Inc. as a supplier? Get its full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2149-2012Class IIPlasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesetsJul 9, 2012

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 13, 2012Palm Harbor, FLDevicesNo Action Indicated (NAI)1000113717
Mar 3, 2011Palm Harbor, FLDevicesVoluntary Action Indicated (VAI)1000113717
Apr 1, 2009Palm Harbor, FLDevicesNo Action Indicated (NAI)1000113717

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K961137ATI PLASMA PUMP (PP-04)Jun 14, 1996
K926409PLASMA DISCARD BAGSMar 2, 1993