510(k) · Cleared
ClearedMRDH Bandage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marine Polymer Technologies, Inc. · KMF Bandage, Liquid
Cleared on Oct 14, 2008 as substantially equivalent to K002550 (Marine Polymer Technologies, Inc., 2000) and 2 other predicates after a 28-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Oct 14, 2008
- Review
- 28 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K013225 (2001). 3 ancestors in all, the oldest K002550 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK013225 Instaclot for Otc Use, Traumasstat for Prescription UseMedafor, Inc. · 2001
- 1 generation backK061722 Bloxx Rapid Clotting AgentCrosslink-D, Inc. · 2006
- This deviceK082703 MRDH BandageMarine Polymer Technologies, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK103641 GuardacareHem Con Medical Technologies, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK140757 D2 Hemostantic DressingZ-Medica, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK243553 QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013225 | Instaclot for Otc Use, Traumasstat for Prescription Use | Medafor, Inc. | 2001 | — |
| −1 | K061722 | Bloxx Rapid Clotting Agent | Crosslink-D, Inc. | 2006 | — |
| 0 (this device) | K082703 | MRDH Bandage | Marine Polymer Technologies, Inc. | 2008 | — |
| +1 | K103641 | Guardacare | Hem Con Medical Technologies, Inc. | 2011 | — |
| +2 | K140757 | D2 Hemostantic Dressing | Z-Medica, LLC | 2014 | — |
| +3 | K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K002550 | RDH BandageSummary page 1…§ 880.5090 G. Classification Name: liquid bandage H. Product Code: KMF I. Predicate Devices: Marine Polymer Technologies, K002550 RDH Bandage T M Medafor, Inc. K013225 Traumadex with Hemadex Clotting… | 2000 |
| * | K013225 | Instaclot for Otc Use, Traumasstat for Prescription UseSummary page 1…Product Code: KMF I. Predicate Devices: Marine Polymer Technologies, K002550 RDH Bandage T M Medafor, Inc. K013225 Traumadex with Hemadex Clotting Beads CrossLink-D, Inc.K0… | 2001 |
| * | K061722 | Bloxx Rapid Clotting AgentSummary page 1…Medafor, Inc. K013225 Traumadex with Hemadex Clotting Beads CrossLink-D, Inc.K061722 Bloxx Rapid Clotting Agent J. Intended Use: mRDHTM Bandage is a trauma dressing intended for the temporary con… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103641 | Guardacare | 2011 | 2 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103641 (Hem Con Medical Technologies, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K002550.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
mRDH Bandage is a trauma dressing intended for the temporary control of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082703 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082703: MRDH Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082703
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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