K761050 is the FDA 510(k) clearance record for HEPARIN PUMP, a class II device, cleared for Dws, Inc. on 1976-12-30 under FDA product code FIR (Pump, Blood, Extra-Luminal). FDA records list 2 510(k) clearances for Dws, Inc. As of 2026-09-10 , FDA records show no recalls naming K761050.
Clearance record Decision date 1976-12-30 Received 1976-11-15 (45 days to decision) Product code FIR Pump, Blood, Extra-LuminalRegulation 21 CFR 876.5820 Device class Class II Review panel Gastroenterology, Urology Applicant Dws, Inc. 803 N. Front St. Suite 3, Mchenry IL Third party review No
Clearances, product code FIR Trailing 12 months FDA records hold no clearances under product code FIR in the trailing twelve months.
FDA records show no clearances under product code FIR in the twelve months to October 2026. Show the numbers FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Product code FIR
Z-2149-2012 Class II On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a due to a complaint received... Apheresis Technologies, Inc. / initiated 2012-07-09 / 13 Z-1654-2012 Apheresis Technologies, Inc., Palm Harbor, FL, initiated a voluntarily withdrawal on November 29, 2010 of their five (5) units of... Apheresis Technologies, Inc. / initiated 2010-11-29 / 5 units Z-1897-2009 Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro... Apheresis Technologies, Inc. / initiated 2009-04-01 / 7 Owner's Manuals
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
