510(k) · Cleared
ClearedApyx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Escala Medical · PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Cleared on Jul 25, 2023 as substantially equivalent to K213783 (Escala Medical, 2022) after a 131-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Jul 25, 2023
- Review
- 131 days
- Class
- Class II
- Product code
- PBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042603 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK042603 Gynecare Prolene Fastener SystemETHICON, Inc. · 2004
- 3 generations backK120831 AnchorsureNeomedic International S.L. · 2012
- 2 generations backK160569 NeuGuidePop Medical Solutions · 2016 · Recalled
- 1 generation backK213783 ApyxEscala Medical · 2022
- This deviceK230730 ApyxEscala Medical · 2023
- Descendant · cites it directly · 0 of its ownK260380 MenditEscala Medical, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260380MenditEscala Medical, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042603 | Gynecare Prolene Fastener System | ETHICON, Inc. | 2004 | — |
| −3 | K120831 | Anchorsure | Neomedic International S.L. | 2012 | — |
| −2 | K160569 | NeuGuide | Pop Medical Solutions | 2016 | 1 |
| −1 | K213783 | Apyx | Escala Medical | 2022 | — |
| 0 (this device) | K230730 | Apyx | Escala Medical | 2023 | — |
| +1 | K260380 | Mendit | Escala Medical, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 12.1 · 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 |
|---|---|---|---|
| * | K213783 | ApyxSummary page 4…trument Regulatory Class: II Product Code: PBQ Product Code Name: Fixation, Non-Absorbable or Absorbable, For Pelvic Use Predicate Device: Escala Medical Ltd., Apyx, K213783 The predicate device has not been subject to a design-related recall. Device Description The Apyx device is indicated for anch… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260380 | Mendit | 2026 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K260380 (Escala Medical, Ltd., 2026) has gone furthest, with 0 descendants of its own.
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. 2023, 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 Apyx is intended for attaching sutures to ligaments of the pelvic floor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230730: Apyx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230730
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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