510(k) · Cleared
Recalled · Class II · 2016Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tz Medical, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on May 11, 2004 as substantially equivalent to K941176 (Adri/Technam, 1994) and 3 other predicates after a 102-day review. Its family tree reaches back 2 generations to 1998. 14 later devices descend from it. It has been recalled once.
- Decided
- May 11, 2004
- Review
- 102 days
- Class
- Class U
- Product code
- QSY
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K984177 (1998). 4 ancestors in all, the oldest K920614 (1992). 14 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK984177 Modification to SkvekpatchMarine Polymer Technologies, Inc. · 1998
- 1 generation backK021062 Chito-SealAbbott Vascular, Inc. · 2002
- This deviceK040208 Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK092503 Radar Vascular Compression DevicesAdvanced Vascular Dynamics · 2009
- Descendant · 2 generations on · 4 of its ownK111837 Radial Artery Compression TourniquetLepu Medical Technology (Beijing) Co., Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK142122 Radar Vascular Compression DeviceAdvanced Vascular Dynamics · 2014
- Descendant · 3 generations on · 3 of its ownK142359 Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd. · 2014
- Descendant · 4 generations on · 1 of its ownK162988 PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K092503Radar Vascular Compression DevicesAdvanced Vascular Dynamics · 2009 · cites it directly9descendants
- K111837Radial Artery Compression TourniquetLepu Medical Technology (Beijing) Co., Ltd. · 2011 · 2 generations on4descendants
- K142122Radar Vascular Compression DeviceAdvanced Vascular Dynamics · 2014 · 2 generations on3descendants
- K142359Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd. · 2014 · 3 generations on3descendants
- K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984177 | Modification to Skvekpatch | Marine Polymer Technologies, Inc. | 1998 | — |
| −1 | K021062 | Chito-Seal | Abbott Vascular, Inc. | 2002 | — |
| 0 (this device) | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band | Tz Medical, Inc. | 2004 | — |
| +1 | K092503 | Radar Vascular Compression Devices | Advanced Vascular Dynamics | 2009 | — |
| +2 | K111837 | Radial Artery Compression Tourniquet | Lepu Medical Technology (Beijing) Co., Ltd. | 2011 | — |
| +2 | K142122 | Radar Vascular Compression Device | Advanced Vascular Dynamics | 2014 | — |
| +3 | K142359 | Vasc Band hemostat | Lepu Medical Technology (Beijing) Co., Ltd. | 2014 | — |
| +4 | K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QSY device
- #1 K240713 Traumagel®score 15.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941176 | Alginate FiberSummary page 5…Unclassified I .DEVICEINFORMATION SUMMARY A. Predicate Device Kalginate by DeRoyal (K941 176) HemoBand (originally manufactured for Innovations for Access by TZ Medical) (K9… | 1994 |
| * | K920614 | Hemo-BandSummary page 5…(K941 176) HemoBand (originally manufactured for Innovations for Access by TZ Medical) (K92061 4) Chito-Seal by Perciose (K02 1062) Syvek Patch by Marine Polymer… | 1992 |
| * | K021062 | Chito-SealSummary page 5…red for Innovations for Access by TZ Medical) (K92061 4) Chito-Seal by Perciose (K02 1062) Syvek Patch by Marine Polymer Technology (K… | 2002 |
| * | K984177 | Modification to SkvekpatchSummary page 5…(K02 1062) Syvek Patch by Marine Polymer Technology (K9841 77) C. Device Description Neptune Pad - Varying size, packaged sterile pads may be used alone as… | 1998 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2016 | Class II | Z-0298-2017 | Labeling Change Control | Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K092503 (Advanced Vascular Dynamics, 2009) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K941176.
How does its category compare?
All QSY devicesQSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QSY
142in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSY
No recall names QSY since 2007.
Adverse event reports per year · QSY
14in 2025
MAUDE reports naming product code QSY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 63 | 0 | 0 |
| 2008 | 7 | 61 | 0 | 0 |
| 2009 | 9 | 55 | 0 | 0 |
| 2010 | 7 | 75 | 0 | 0 |
| 2011 | 8 | 137 | 0 | 0 |
| 2012 | 7 | 239 | 0 | 0 |
| 2013 | 3 | 161 | 0 | 0 |
| 2014 | 6 | 249 | 0 | 0 |
| 2015 | 6 | 171 | 0 | 0 |
| 2016 | 5 | 161 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 186 | 0 | 0 |
| 2019 | 4 | 336 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 7 | 586 | 0 | 0 |
| 2024 | 4 | 142 | 0 | 3 |
| 2025 | 2 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (145 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040208 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040208: Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040208
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026