510(k) · Cleared
ClearedHospal Tipstop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Healthcare · KMF Bandage, Liquid
Cleared on Oct 21, 1998 as substantially equivalent to K896068 (Gambro-Hospal, Inc., 1990) after a 71-day review. Its family tree reaches back 1 generation to 1990. 46 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 71 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896068 (1990). 46 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- This deviceK982818 Hospal TipstopGambro Healthcare · 1998
- Descendant · cites it directly · 45 of its ownK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- Descendant · cites it directly · 44 of its ownK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 25 of its ownK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- Descendant · 3 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · 2 generations on · 16 of its ownK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K012293Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002 · cites it directly45descendants
- K030836D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · cites it directly44descendants
- K050511Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005 · 2 generations on25descendants
- K072900Excelarrest FoamHemostasis, LLC · 2007 · 3 generations on19descendants
- K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| 0 (this device) | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| +1 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| +1 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| +2 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| +3 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +2 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 KMF? 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 KMF device
- #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K896068 | Tipstop (TM)Summary page 1…k) Notification is identical in indications for use, labeling and materials to the previously cleared Hospal TIPSTOP which was cleared by the FDA on September 10", 1990 (K896068) with one exception. The material on the compression body has been changed from lyophilized bovine collagen to lyophilized algin… | 1990 |
What descends from it? (46)
See all 462 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K012293 (Vascular Solutions, Inc., 2002) has gone furthest, with 45 descendants of its own.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 2025
MAUDE reports naming product code KMF, 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 | 2 | — | 1 | 6 |
| 2008 | 3 | 35 | 0 | 2 |
| 2009 | 3 | 213 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TIPSTOP is intended to be used as a sterile compression dressing for puncture of the vascular access site.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982818: Hospal Tipstop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982818
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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