510(k) · Cleared
ClearedBusse Umbilical Cord Clamp Cutter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Busse Hospital Disposables, Inc. · HFW Clamp, Umbilical
Cleared on Apr 29, 2002 as substantially equivalent to K010835 (Busse Hospital Disposables, Inc., 2001) and 2 other predicates after a 28-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Apr 29, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- HFW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K781548 (1978). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK781548 Umbilical Cord ClampHollister, Inc. · 1978
- This deviceK021055 Busse Umbilical Cord Clamp CutterBusse Hospital Disposables, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781548 | Umbilical Cord Clamp | Hollister, Inc. | 1978 | — |
| 0 (this device) | K021055 | Busse Umbilical Cord Clamp Cutter | Busse Hospital Disposables, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K010835 | Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp…Summary page 1…e Umbilical Cord Clamp Cutter Common Name/Classification Name: Umbilical Cord Clamp Cutter Predicate Device [21 CFR 807.92(a)(3)] e Busse Posi-Grip Umbilical Cord Clamp K010835 e Precision Dynamics Corporation Umbilical Cord Clamp Cutter K994263 e Hollister Umbilical Cord Clamp Cutter K781548 Description… | 2001 |
| * | K994263 | Securline Umbilical Cord Clamp Clipper #3540Summary page 1…cal Cord Clamp Cutter Predicate Device [21 CFR 807.92(a)(3)] e Busse Posi-Grip Umbilical Cord Clamp K010835 e Precision Dynamics Corporation Umbilical Cord Clamp Cutter K994263 e Hollister Umbilical Cord Clamp Cutter K781548 Description of the Device [21 CFR 807.92(a)(4)] The subject device is a cutter d… | 2000 |
| * | K781548 | Umbilical Cord ClampSummary page 1…807.92(a)(3)] e Busse Posi-Grip Umbilical Cord Clamp K010835 e Precision Dynamics Corporation Umbilical Cord Clamp Cutter K994263 e Hollister Umbilical Cord Clamp Cutter K781548 Description of the Device [21 CFR 807.92(a)(4)] The subject device is a cutter designed to safely cut the umbilical cord clamp.… | 1978 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
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 intended use is to cut the umbilical cord clamp off a newborn’s umbilical 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/K021055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021055: Busse Umbilical Cord Clamp Cutter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021055
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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