# K040208: Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band

- Pathway: 510(k) (Traditional)
- Applicant: Tz Medical, Inc.
- Decided: May 11, 2004 after 102 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K984177 (1998). 4 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941176: Alginate Fiber, Adri/Technam (1994) Summary page 5.
- K920614: Hemo-Band, Innovations IN Access, Inc. (1992) Summary page 5.
- K021062: Chito-Seal, Abbott Vascular, Inc. (2002) Summary page 5.
- K984177: Modification to Skvekpatch, Marine Polymer Technologies, Inc. (1998) Summary page 5.

## Most influential descendants
- K092503: Radar Vascular Compression Devices (2009), 9 descendants of its own
- K111837: Radial Artery Compression Tourniquet (2011), 4 descendants of its own
- K142122: Radar Vascular Compression Device (2014), 3 descendants of its own
- K142359: Vasc Band hemostat (2014), 3 descendants of its own
- K162988: PreludeSYNC Radial Compression Device (2017), 1 descendant of its own

## Recalls of this device
- Jul 7, 2016 · Class II · Z-0298-2017: Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label.

## Indications for use
Neptune Pad (calcium alginate pad alone): 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 therapy. Neptune Comfort-Band (Pressure Band with calcium alginate pad): Neptune Comfort-Band is used to provide pressure and promote the rapid control of bleeding and promote hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis. Comfort-Band (Pressure Band alone): Comfort-Band is used to provide pressure and promote the rapid control of bleeding and hemostasis following needle puncture, arterial/venous catheterization and access sites, including patients on anticoagulation therapy, and following hemodialysis. It may be used alone, with Neptune Pad, with sterile gauze or other sterile wound dressings.

Source page: https://510kreport.com/device/K040208
Methodology: https://510kreport.com/methodology