510(k) · Cleared
ClearedPipeline II Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · GZT Retractor, Self-Retaining, For Neurosurgery
Cleared on Dec 15, 2006 as substantially equivalent to K992898 (Bright Medical Instruments, 1999) after an 86-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Dec 15, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- GZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992898 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992898 The Bright Medical Dilation Retractor SystemBright Medical Instruments · 1999
- This deviceK062814 Pipeline II Access SystemDepuy Spine, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK113273 Spotlight Access SystemJohnson & Johnson · 2012
- Descendant · cites it directly · 0 of its ownK112913 Spotlight Access SystemJohnson & Johnson · 2011
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 |
|---|---|---|---|---|---|
| −1 | K992898 | The Bright Medical Dilation Retractor System | Bright Medical Instruments | 1999 | — |
| 0 (this device) | K062814 | Pipeline II Access System | Depuy Spine, Inc. | 2006 | — |
| +1 | K113273 | Spotlight Access System | Johnson & Johnson | 2012 | — |
| +1 | K112913 | Spotlight Access System | Johnson & Johnson | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 GZT? 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 GZT device
- #1 K252995 Durashield Device Kitscore 12.6 · 3 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 |
|---|---|---|---|
| * | K992898 | The Bright Medical Dilation Retractor SystemSummary page 1…For Neurosurgery §882.4800 PROPRIETARY NAME: PIPELINE 1IAccess System PREDICATE DEVICE: Bright Medical Dilation Retractor System, K992898 DEVICE DESCRIPTION: The PIPELINE 11Access System consists of a series of dilators and tubular retra… | 1999 |
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?
How does its category compare?
All GZT devicesGZT Retractor, Self-Retaining, For Neurosurgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZT
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GZT
280in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZT
1in 2012
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GZT
1in 2025
MAUDE reports naming product code GZT, 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 | 2 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 1 (1) | 6 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 3 | 280 | 0 | 9 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PIPELINE Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the lamina, with its attachment to a rigid arm to provide a self-locking method of access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062814: Pipeline II Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062814
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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