510(k) · Cleared
ClearedApple Medical/OB Mobius Elastic Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple Medical Corp. · GAD Retractor
Cleared on Apr 26, 2005 as substantially equivalent to K041131 (Apple Medical Corp., 2004) after an 82-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 26, 2005
- Review
- 82 days
- Class
- Class I
- Product code
- GAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954824 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- 2 generations backK014005 Apple Medical Mobius Elastic RetractorApple Medical Corp. · 2002
- 1 generation backK041131 Apple Medical OB Mobius Elastic RetractorApple Medical Corp. · 2004
- This deviceK050256 Apple Medical/OB Mobius Elastic RetractorApple Medical Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954824 | Protector Retractor & Protector Retractor with Drape | Medical Creative Technologies, Inc. | 1996 | — |
| −2 | K014005 | Apple Medical Mobius Elastic Retractor | Apple Medical Corp. | 2002 | — |
| −1 | K041131 | Apple Medical OB Mobius Elastic Retractor | Apple Medical Corp. | 2004 | — |
| 0 (this device) | K050256 | Apple Medical/OB Mobius Elastic Retractor | Apple Medical Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 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? (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 |
|---|---|---|---|
| * | K041131 | Apple Medical OB Mobius Elastic RetractorSummary page 1…Obstetric-gynecologic specialized manual instrument (884.4530) Predicate Devices The Apple Medical OB/Mobius® Elastic Retractor (K041131) and 510(k) exempt mechanical abdominal retractors used in cesarean section. Description The App… | 2004 |
| * | — | 510(k) exempt mechanical abdominal retractors used in cesarean section Named without a submission number |
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 9 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
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 | — |
What is it indicated for?
The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in non-urgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050256: Apple Medical/OB Mobius Elastic Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050256
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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