NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND— 510(k) K040208

Clearance details

Applicant

Tz Medical, Inc.

Product code

Code QSY

Device class

Unclassified

Advisory panel

Unknown

Date received

2004-01-30

Decision date

2004-05-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Portland, OR, US

• K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20)2026-04-30
• K251700 — Ganymede 2cm diameter (FG100300) +14 more2026-02-26
• K250319 — MFUSE (MS001)2025-12-15
• K253609 — TRAUMAGEL® 2.0 Hemostatic Gel2025-12-12
• K240713 — TRAUMAGEL®2024-08-14

• K252772 — Arc Adjustable Radial Cuff Compression Device2026-05-22
• K173563 — ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE2018-01-10
• K163322 — TZ SKULL PIN Adult2017-02-23
• K102507 — AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR2011-06-13
• K062577 — V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC2006-12-15

Death

5

Other

1

Total

6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0298-2017 — Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapyClass II·Terminated·TZ Medical, Inc.·20160707

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040208.