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. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 13, 2004 as substantially equivalent to K031889 (Applied Medical Resources Corp., 2003) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- May 13, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954824 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- 1 generation backK014005 Apple Medical Mobius Elastic RetractorApple Medical Corp. · 2002
- This deviceK041131 Apple Medical OB Mobius Elastic RetractorApple Medical Corp. · 2004
- Descendant · cites it directly · 0 of its ownK050256 Apple Medical/OB Mobius Elastic RetractorApple Medical Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K050256Apple Medical/OB Mobius Elastic RetractorApple Medical Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954824 | Protector Retractor & Protector Retractor with Drape | Medical Creative Technologies, Inc. | 1996 | — |
| −1 | K014005 | Apple Medical Mobius Elastic Retractor | Apple Medical Corp. | 2002 | — |
| 0 (this device) | K041131 | Apple Medical OB Mobius Elastic Retractor | Apple Medical Corp. | 2004 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K031889 | Alexis Wound RetractorSummary page 1…21 CFR §876.1500, ProCode GCJ Predicate Devices AlexiSTM Wound Retractor Mobius Elastic Retractor K031889 K014005 Description The Apple Medical OB Mobius Elastic Retractor is used for… | 2003 |
| * | K014005 | Apple Medical Mobius Elastic RetractorSummary page 1…Predicate Devices AlexiSTM Wound Retractor Mobius Elastic Retractor K031889 K014005 Description The Apple Medical OB Mobius Elastic Retractor is used for lapa… | 2002 |
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 |
|---|---|---|---|
| K050256 | Apple Medical/OB Mobius Elastic Retractor | 2005 | 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 8 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050256 (Apple Medical Corp., 2005) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031889.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Apple Medical OB Mobius is indicated for use to assist in laparotomy procedures. It is intended to provide incision retraction and to protect against wound contamination during open surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041131: 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/K041131
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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