PMA · Approved
Recalled · Class II · 2014Falope Ring Band and Applicator Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · KNH Laparoscopic Contraceptive Tubal Occlusion Device
Approved on Sep 29, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 2,123-day review. It has been recalled 3 times.
- Decided
- Sep 29, 1993
- Review
- 2,123 days
- Class
- Class III
- Product code
- KNH
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P870076 has 26 supplements since 1996: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1996 | 4 |
| 1997 | 1 |
| 1999 | 1 |
| 2007 | 1 |
| 2010 | 3 |
| 2012 | 2 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 6 |
| 2017 | 1 |
| 2020 | 2 |
| 2021 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNH? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2014 | Class II | Z-0419-2015 | Process control | All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection. |
| Jul 8, 2014 | Class II | Z-2269-2014 | Packaging process control | Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator. |
| Feb 19, 2014 | Class II | Z-1196-2014 | Process design | Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KNH devicesKNH Laparoscopic Contraceptive Tubal Occlusion Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KNH
Too few KNH 510(k)s in any year since 2007 to give a median.
Recalls per year · KNH
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNH
7in 2025
MAUDE reports naming product code KNH, 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 | 1 | — | 0 | 17 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 4 | — | 0 | 21 |
| 2010 | 9 | — | 0 | 24 |
| 2011 | 12 | — | 0 | 50 |
| 2012 | 5 | — | 0 | 49 |
| 2013 | 0 | — | 0 | 25 |
| 2014 | 2 | — | 2 | 48 |
| 2015 | 1 | — | 0 | 60 |
| 2016 | 9 | — | 0 | 61 |
| 2017 | 2 | — | 0 | 105 |
| 2018 | 0 | — | 0 | 114 |
| 2019 | 1 | — | 0 | 60 |
| 2020 | 2 | — | 0 | 48 |
| 2021 | 2 | — | 0 | 24 |
| 2022 | 1 | — | 0 | 20 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P870076 · printed Nov 3, 2026
Cite this page
510(k) Report. “P870076: Falope Ring Band and Applicator Systems.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P870076
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026