510(k) · Cleared
Cleared#556 Disposable Umbilical Cord Clamp (2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha Unlimited, Inc. · HFW Clamp, Umbilical
Cleared on Sep 5, 1989 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Sep 5, 1989
- Review
- 43 days
- Class
- Class II
- Product code
- HFW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK894646 #556 Disposable Umbilical Cord Clamp (2)Alpha Unlimited, Inc. · 1989
- Descendant · cites it directly · 1 of its ownK990737 'Ecurline Umbilical Cord Clamp #3500Precision Dynamics Corp. · 1999
- Descendant · cites it directly · 0 of its ownK020718 Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterilePrecision Dynamics Corp. · 2002
- Descendant · 2 generations on · 0 of its ownK994367 Umbilical Cord ClampMedical Sales Co. · 2000
Most influential descendants
Showing 3 of 3 · See all- K990737'Ecurline Umbilical Cord Clamp #3500Precision Dynamics Corp. · 1999 · cites it directly1descendant
- K020718Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterilePrecision Dynamics Corp. · 2002 · cites it directly0descendants
- K994367Umbilical Cord ClampMedical Sales Co. · 2000 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894646 | #556 Disposable Umbilical Cord Clamp (2) | Alpha Unlimited, Inc. | 1989 | — |
| +1 | K990737 | 'Ecurline Umbilical Cord Clamp #3500 | Precision Dynamics Corp. | 1999 | — |
| +1 | K020718 | Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-Sterile | Precision Dynamics Corp. | 2002 | — |
| +2 | K994367 | Umbilical Cord Clamp | Medical Sales Co. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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, K990737 (Precision Dynamics Corp., 1999) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K894646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894646: #556 Disposable Umbilical Cord Clamp (2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894646
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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