510(k) · Cleared
ClearedSaffron Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Cleared on Jun 10, 2022 as substantially equivalent to K120831 (Neomedic International S.L., 2012) after a 116-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Jun 10, 2022
- Review
- 116 days
- Class
- Class II
- Product code
- PBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042603 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 PBQ? 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 PBQ device
- #1 K260380 Menditscore 12.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K120831 | AnchorsureSummary page 4…Pelvic Use) Regulatory Class: II III. PREDICATE DEVICE Anchorsure, 510(k)-cleared on October 12, 2012 under K120831. The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Saffron Fixation System c… | 2012 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K120831.
How does its category compare?
All PBQ devicesPBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PBQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PBQ
Too few PBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PBQ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBQ
5in 2025
MAUDE reports naming product code PBQ, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220420: Saffron Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220420
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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