510(k) · Cleared
Recalled · Class II · 2026Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Innovations, Inc. · HDB Extractor, Vacuum, Fetal
Cleared on Sep 22, 1998 as substantially equivalent to K890307 (Neward Enterprises, Inc., 1989) and 5 other predicates after a 169-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 22, 1998
- Review
- 169 days
- Class
- Class II
- Product code
- HDB
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 2 generations to K890307 (1989). 6 ancestors in all, the oldest K881967 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK890307 Mityvac M Style Vacuum Extractor, DisposableNeward Enterprises, Inc. · 1989
- 1 generation backK970170 Swift Delivery Product #002-Vac EX Cup W/Vac Rel ValveRichard G. Lindsay · 1997
- This deviceK981260 Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom…Clinical Innovations, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK250298 Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi®…Clinical Innovations, LLC · 2025
- Descendant · cites it directly · 0 of its ownK043614 Vaculink, Model VCL 3000Medevco, Inc. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890307 | Mityvac M Style Vacuum Extractor, Disposable | Neward Enterprises, Inc. | 1989 | — |
| −1 | K970170 | Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve | Richard G. Lindsay | 1997 | — |
| 0 (this device) | K981260 | Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with… | Clinical Innovations, Inc. | 1998 | — |
| +1 | K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete… | Clinical Innovations, LLC | 2025 | — |
| +1 | K043614 | Vaculink, Model VCL 3000 | Medevco, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 HDB? 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 HDB device
- #1 K250298 Kiwi® Complete Vacuum Delivery System…score 10.7 · 3 generations · no Class I recall
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K890307 | Mityvac M Style Vacuum Extractor, DisposableSummary page 1…al Vacuum Extractor Classification Name: Extractor, Vacuum, Fetal The legally marketed devices to which equivalence is claimed are: Mityvac “M” style vacuum extractor (K890307), Mityvac Super “M” Style vacuum extractor (K943928), Mityvac Obstetric Vac Deliv. Kit w/ Univ. VAC REL (K934011), CMI Velvet Tou… | 1989 |
| * | K943938 | Mityvac Super M Style Vacum Extractor, Disposable Our OCR of the scanned summary read K943928, FDA’s number for Apilus Electropil (Dectro Intl., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mityvac Super “M” Style vacuum extractor”. | 1995 |
| * | K934011 | Mityvac (R) Obstetric Vac Deliv Kit W/Univ Vac ReleaseSummary page 1…ence is claimed are: Mityvac “M” style vacuum extractor (K890307), Mityvac Super “M” Style vacuum extractor (K943928), Mityvac Obstetric Vac Deliv. Kit w/ Univ. VAC REL (K934011), CMI Velvet Touch Vacuum Extractor (K942725), CMI Vacuum Pump #001C (K881967) and Swift Delivery Product #002 (K970170). o Desc… | 1994 |
| * | K942725 | Cmi Velvet Touch Vacuum ExtractorSummary page 1…extractor (K890307), Mityvac Super “M” Style vacuum extractor (K943928), Mityvac Obstetric Vac Deliv. Kit w/ Univ. VAC REL (K934011), CMI Velvet Touch Vacuum Extractor (K942725), CMI Vacuum Pump #001C (K881967) and Swift Delivery Product #002 (K970170). o Description of the device: The Kiwi Complete Vacu… | 1995 |
| * | K881967 | Cmi Vacuum Pump #001C - Vacuum Pump (Non-Electri.)Summary page 1…er “M” Style vacuum extractor (K943928), Mityvac Obstetric Vac Deliv. Kit w/ Univ. VAC REL (K934011), CMI Velvet Touch Vacuum Extractor (K942725), CMI Vacuum Pump #001C (K881967) and Swift Delivery Product #002 (K970170). o Description of the device: The Kiwi Complete Vacuum Delivery Systems are fetal vac… | 1988 |
| * | K970170 | Swift Delivery Product #002-Vac EX Cup W/Vac Rel ValveSummary page 1…ityvac Obstetric Vac Deliv. Kit w/ Univ. VAC REL (K934011), CMI Velvet Touch Vacuum Extractor (K942725), CMI Vacuum Pump #001C (K881967) and Swift Delivery Product #002 (K970170). o Description of the device: The Kiwi Complete Vacuum Delivery Systems are fetal vacuum extractors having a cup to attach to t… | 1997 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2026 | Class II | Z-1945-2026 | Under Investigation by firm | Due to complaints of device breakage at the traction force gauge to handle joint. |
| Aug 6, 2019 | Class II | Z-2072-2020 | Process control | There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K250298 (Clinical Innovations, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K890307.
How does its category compare?
All HDB devicesHDB Extractor, Vacuum, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HDB
Too few HDB 510(k)s in any year since 2007 to give a median.
Recalls per year · HDB
3in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HDB
17in 2025
MAUDE reports naming product code HDB, 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 | 25 |
| 2008 | 0 | — | 3 | 35 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 0 | — | 0 | 24 |
| 2021 | 0 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 24 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Standard vacuum extraction Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions. Trial of vacuum extraction Vacuum delivery should be regarded as a “trial” 1) if there is arrest of descent in the second stage…
Read the full statement (136 words)
Standard vacuum extraction
Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions.
Trial of vacuum extraction
Vacuum delivery should be regarded as a “trial” 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known.
Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions, 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches (“pops-off”) twice.
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/K981260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981260: Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981260
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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