510(k) · Cleared
ClearedMedela Single Use Silc Cup, Model 077.0791
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela AG · HDB Extractor, Vacuum, Fetal
Cleared on Apr 21, 2005 as substantially equivalent to K841492 (Medela, Inc., 1984) and 1 other predicate after a 311-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Apr 21, 2005
- Review
- 311 days
- Class
- Class II
- Product code
- HDB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K841492 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK841492 AB Vacuum Extractor Silc-CupMedela, Inc. · 1984
- This deviceK041579 Medela Single Use Silc Cup, Model 077.0791Medela AG · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841492 | AB Vacuum Extractor Silc-Cup | Medela, Inc. | 1984 | — |
| 0 (this device) | K041579 | Medela Single Use Silc Cup, Model 077.0791 | Medela AG | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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? (2)
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 |
|---|---|---|---|
| * | K841492 | AB Vacuum Extractor Silc-CupSummary page 1…884.4340). 3 Product Code HDB 4 Name of the predicate Device(s) Medela Inc. OB Vacuum Extractor (K841492) Hollister Inc. Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor (K895700) A… | 1984 |
| * | K895700 | Ameda/Egnell Dolphin Dispo-Soft Vacuum ExtractorSummary page 1…OB Vacuum Extractor (K841492) Hollister Inc. Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor (K895700) Applicant: Medela AG, Laettichstrasse 4b. CH-6341 Baar, Switzerland Contact Person: Werner Frei, Tel ±41… | 1990 |
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 2 ancestors has a recall.
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?
Fetal distress in the second stage
Maternal delay in the second stage
Maternal conditions requiring a short second stage
The Medela® Obstetrical Vacuum Delivery System (Single Use Sile Cup) is a sterile, disposable device intended to be used to facilitate the delivery of the fetus during childbirth. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp. It is powered by an external vacuum source and indicated for using during vaginal or cesarean delivery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041579 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041579: Medela Single Use Silc Cup, Model 077.0791.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041579
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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