510(k) · Cleared
ClearedKoala Clamp, Koala Clamp and Cutter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maternus, Inc. · HFW Clamp, Umbilical
Cleared on Aug 10, 2001 as substantially equivalent to K982464 (Women First Healthcare, Inc., 1998) after a 77-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Aug 10, 2001
- Review
- 77 days
- Class
- Class II
- Product code
- HFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963428 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK963428 Umbilical Clamp and CutterR.O.S.T. Medical Development, Inc. · 1997
- 1 generation backK982464 SCC-23 Safety Clamp and CutterWomen First Healthcare, Inc. · 1998
- This deviceK011621 Koala Clamp, Koala Clamp and CutterMaternus, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK152350 Regular and Special Umbilical Cord Clamp and CutterNingbo Feite Medical Device Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152350Regular and Special Umbilical Cord Clamp and CutterNingbo Feite Medical Device Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963428 | Umbilical Clamp and Cutter | R.O.S.T. Medical Development, Inc. | 1997 | — |
| −1 | K982464 | SCC-23 Safety Clamp and Cutter | Women First Healthcare, Inc. | 1998 | — |
| 0 (this device) | K011621 | Koala Clamp, Koala Clamp and Cutter | Maternus, Inc. | 2001 | — |
| +1 | K152350 | Regular and Special Umbilical Cord Clamp and Cutter | Ningbo Feite Medical Device Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 HFW? 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
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 |
|---|---|---|---|
| * | K982464 | SCC-23 Safety Clamp and CutterSummary page 1…IV. Substantial Equivalence: The Koala Clamp & Cutter is substantially equivalent to the ClampCut by Pricelnvena APS, a legally marketed device in the US. [510(k) No. 982464] V. Statement of Intended Use: The indications for use of the Koala Clamp & are to simultaneously clamp and cut the umbilical c… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152350 | Regular and Special Umbilical Cord Clamp and Cutter | 2016 | 0 |
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 4 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152350 (Ningbo Feite Medical Device Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HFW devicesHFW Clamp, Umbilical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HFW
FDA has decided no HFW device since 2007.
Median 510(k) review, days · HFW
Too few HFW 510(k)s in any year since 2007 to give a median.
Recalls per year · HFW
No recall names HFW since 2007.
Adverse event reports per year · HFW
2in 2024
MAUDE reports naming product code HFW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbitical cord.
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/K011621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011621: Koala Clamp, Koala Clamp and Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011621
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026