510(k) · Cleared
ClearedRDH 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 Dec 20, 2000 after a 125-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 99 later devices descend from it.
- Decided
- Dec 20, 2000
- Review
- 125 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 0
99 later devices descend from it, 4 citing it directly.
- This deviceK002550 RDH BandageMarine Polymer Technologies, Inc. · 2000
- Descendant · cites it directly · 74 of its ownK023298 Hemcon BandageHemcon, Inc. · 2002
- Descendant · cites it directly · 64 of its ownK013390 QuickclotOn Site Gas Systems, Inc. · 2002
- Descendant · 2 generations on · 56 of its ownK030946 Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003
- Descendant · 2 generations on · 55 of its ownK043050 Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005
- Descendant · 2 generations on · 42 of its ownK051955 Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K023298Hemcon BandageHemcon, Inc. · 2002 · cites it directly74descendants
- K013390QuickclotOn Site Gas Systems, Inc. · 2002 · cites it directly64descendants
- K030946Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003 · 2 generations on56descendants
- K043050Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005 · 2 generations on55descendants
- K051955Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation · 2005 · 2 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002550 | RDH Bandage | Marine Polymer Technologies, Inc. | 2000 | — |
| +1 | K023298 | Hemcon Bandage | Hemcon, Inc. | 2002 | — |
| +1 | K013390 | Quickclot | On Site Gas Systems, Inc. | 2002 | — |
| +2 | K030946 | Hemcon Bandage Otc; Hemcon Cath/Aid | Hemcon, Inc. | 2003 | — |
| +2 | K043050 | Hemcon Bandage and Hemcon Bandage Otc | Hemcon, Inc. | 2005 | — |
| +2 | K051955 | Quickclot Acs - Accelerated Clotting Sponge | Z-Medica Corporation | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (99)
See all 994 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?
- Of its descendants, K023298 (Hemcon, Inc., 2002) has gone furthest, with 74 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 | — |
https://510kreport.com/device/K002550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002550: RDH Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002550
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026