510(k) · Cleared
ClearedRetractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Automated Medical Products Corp. · GAD Retractor
Cleared on May 17, 1994 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 17, 1994
- Review
- 22 days
- Class
- Class I
- Product code
- GAD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK942002 RetractorAutomated Medical Products Corp. · 1994
- Descendant · cites it directly · 2 of its ownK133345 Reveel Endoscopic RetractorRetraction Limited · 2014
- Descendant · 2 generations on · 1 of its ownK162445 LiVac Retractor SystemLivac Pty, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK243399 Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC · 2025
- Descendant · cites it directly · 0 of its ownK112659 Surgical RetractorsSurgical Innovations Plc · 2012
Most influential descendants
Showing 4 of 4 · See all- K133345Reveel Endoscopic RetractorRetraction Limited · 2014 · cites it directly2descendants
- K162445LiVac Retractor SystemLivac Pty, Ltd. · 2016 · 2 generations on1descendant
- K243399Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC · 2025 · 3 generations on0descendants
- K112659Surgical RetractorsSurgical Innovations Plc · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942002 | Retractor | Automated Medical Products Corp. | 1994 | — |
| +1 | K133345 | Reveel Endoscopic Retractor | Retraction Limited | 2014 | — |
| +2 | K162445 | LiVac Retractor System | Livac Pty, Ltd. | 2016 | — |
| +3 | K243399 | Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC | 2025 | — |
| +1 | K112659 | Surgical Retractors | Surgical Innovations Plc | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAD? 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133345 (Retraction Limited, 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GAD devicesGAD Retractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAD
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GAD
Too few GAD 510(k)s in any year since 2007 to give a median.
Recalls per year · GAD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAD
107in 2025
MAUDE reports naming product code GAD, 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 | 38 |
| 2008 | 0 | — | 1 | 45 |
| 2009 | 0 | — | 1 | 64 |
| 2010 | 0 | — | 0 | 52 |
| 2011 | 0 | — | 0 | 50 |
| 2012 | 0 | — | 0 | 80 |
| 2013 | 1 | — | 3 | 88 |
| 2014 | 0 | — | 2 | 80 |
| 2015 | 0 | — | 1 | 67 |
| 2016 | 2 | — | 0 | 78 |
| 2017 | 0 | — | 0 | 90 |
| 2018 | 0 | — | 0 | 77 |
| 2019 | 0 | — | 0 | 62 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 81 |
| 2022 | 0 | — | 1 | 80 |
| 2023 | 0 | — | 0 | 80 |
| 2024 | 0 | — | 1 | 111 |
| 2025 | 0 | — | 0 | 107 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K942002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942002: Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026