510(k) · Cleared
ClearedSoftFix Balloon Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimax Medical Systems, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 5, 2021 as substantially equivalent to K060629 (Applied Medical Resources Corp., 2006) and 1 other predicate after a 168-day review. Its family tree reaches back 4 generations to 1999. 2 later devices descend from it.
- Decided
- Nov 5, 2021
- Review
- 168 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K990028 (1999). 8 ancestors in all, the oldest K924011 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK990028 Endopath Optiview Optical Surgical Obturator and SleeveEthicon Endo-Surgery, Inc. · 1999
- 3 generations backK032889 Optical SeparatorApplied Medical Resources · 2003
- 2 generations backK060096 Modular Trocar SystemApplied Medical Resources Corp. · 2006 · Recalled
- 1 generation backK083638 Fixation TrocarsApplied Medical Resources Corp. · 2008 · Recalled
- This deviceK211577 SoftFix Balloon TrocarUnimax Medical Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK252714 C-Lant PortVigor Medical Technologies, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK233263 Disposable TrocarsHangzhou Kangji Medical Instrument Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990028 | Endopath Optiview Optical Surgical Obturator and Sleeve | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −3 | K032889 | Optical Separator | Applied Medical Resources | 2003 | — |
| −2 | K060096 | Modular Trocar System | Applied Medical Resources Corp. | 2006 | 7 |
| −1 | K083638 | Fixation Trocars | Applied Medical Resources Corp. | 2008 | 1 |
| 0 (this device) | K211577 | SoftFix Balloon Trocar | Unimax Medical Systems, Inc. | 2021 | — |
| +1 | K252714 | C-Lant Port | Vigor Medical Technologies, Ltd. | 2026 | — |
| +1 | K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K060629 | Gelport Blunt Tip Trocar SystemSummary page 4…® Device Name GelPort Blunt Tip Trocar System 510(k) Number K060629 Applied Medical Resources Corporation Manufacturer 228… | 2006 |
| * | K083638 | Fixation TrocarsSummary page 4…Description Device Name Fixation Trocars 510(k) Number K083638 Applied Medical Resources Corporation Manufacturer 228… | 2008 |
What descends from it? (2)
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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K252714 (Vigor Medical Technologies, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060629.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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 SoftFixTM Balloon Trocar have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211577: SoftFix Balloon Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211577
Report an extraction error
Are you the manufacturer?
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