510(k) Report

510(k) · Cleared

Cleared

Tipstop (TM)

K896068510(k) TraditionalCleared Sep 10, 1990326-day reviewClass I21 CFR 880.5240

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gambro-Hospal, Inc. · KGX Tape And Bandage, Adhesive

Cleared on Sep 10, 1990 after a 326-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.

Decided
Sep 10, 1990
Review
326 days
Class
Class I
Product code
KGX
Recalls
None
Predicates
0

47 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2003: 1 descendant cleared2002: 1 descendant cleared2007: 7 descendants cleared2006: 3 descendants cleared2005: 4 descendants cleared2004: 1 descendant cleared2020: 1 descendant cleared2009: 2 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2008: 3 descendants cleared2015: 3 descendants cleared2012: 1 descendant cleared2013: 2 descendants cleared2019: 3 descendants cleared2018: 3 descendants cleared2014: 2 descendants cleared2022: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2023: 2 descendants cleared1990200020102020
  1. This deviceK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
  2. Descendant · cites it directly · 46 of its ownK982818 Hospal TipstopGambro Healthcare · 1998
  3. Descendant · 2 generations on · 45 of its ownK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
  4. Descendant · 2 generations on · 44 of its ownK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
  5. Descendant · 3 generations on · 25 of its ownK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
  6. Descendant · 4 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

1998: 12002: 12003: 12004: 12005: 42006: 32007: 72008: 32009: 22010: 12011: 12012: 12013: 22014: 22015: 32016: 12017: 12018: 32019: 32020: 12021: 12022: 12023: 22024: 1
1998high 7 (2007) · low 0 (1999)2026

Most influential descendants

Showing 5 of 47 · See all
  • K982818Hospal TipstopGambro Healthcare · 1998 · cites it directly46descendants
  • K012293Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002 · 2 generations on45descendants
  • K030836D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · 2 generations on44descendants
  • K050511Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005 · 3 generations on25descendants
  • K072900Excelarrest FoamHemostasis, LLC · 2007 · 4 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896068Tipstop (TM)Gambro-Hospal, Inc.1990—
+1K982818Hospal TipstopGambro Healthcare1998—
+2K012293Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc.2002—
+2K030836D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc.20033
+3K050511Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.2005—
+4K072900Excelarrest FoamHemostasis, LLC2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
200310
200410
200540
200630
200770
200830
200920
201010
201110
201210
201320
201420
201530
201610
201710
201830
201930
202010
202110
202210
202320
202410
FIG. 1 — Lineage of K896068, 1990–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (47)

See all 47

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982818Hospal TipstopGambro Healthcare199846

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?

  • Of its descendants, K982818 (Gambro Healthcare, 1998) has gone furthest, with 46 descendants of its own.

How does its category compare?

All KGX devices

KGX Tape And Bandage, Adhesive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGX

FDA has decided no KGX device since 2007.

Median 510(k) review, days · KGX

Too few KGX 510(k)s in any year since 2007 to give a median.

Recalls per year · KGX

8in 2025

2010: 82011: 42012: 22015: 32019: 12025: 8
2007high 8 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGX

317in 2025

2007: 372008: 262009: 372010: 312011: 392012: 592013: 882014: 982015: 2002016: 1582017: 2062018: 2132019: 4882020: 1,2902021: 5622022: 2532023: 1922024: 2242025: 317
2007high 1,290 (2020) · low 26 (2008)2025

MAUDE reports naming product code KGX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—037
20080—026
20090—037
20100—831
20110—439
20120—259
20130—088
20140—098
20150—3200
20160—0158
20170—0206
20180—0213
20190—1488
20200—01,290
20210—0562
20220—0253
20230—0192
20240—0224
20250—8317
20260—0—

More from Gambro-Hospal, Inc.

3 FDA decisions under this applicant name. See the company

  • K902588BSM/21&22 SC Blood Safe Mod & V.P.M. Ven Press ModGambro-Hospal, Inc. · 1991
  • K901368Hemospal Kits A1, A2D, AO, & A1DGambro-Hospal, Inc. · 1990

Recent decisions in KGX

The KGX category page

  • K001240Seragard Injection PatchPlatinum Services, Inc. · 2000
  • K983368Care Band Antibacterial BandagesAso Corp. · 1999
  • K972914Syvek PatchMarine Polymer Technologies, Inc. · 1997
  • K943314Adhesive Bandages with Otc DrugJohnson & Johnson Consumer Products, Inc. · 1996
  • K952606Targett PatchCutting Edge Technologies, Inc. · 1995

https://510kreport.com/device/K896068 · printed Nov 4, 2026

Cite this page

510(k) Report. “K896068: Tipstop (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896068

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026