510(k) · Cleared
ClearedZmed VP4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zmed, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 12, 2013 as substantially equivalent to K962260 (Digivision, Inc., 1996) after a 9-day review. Its family tree reaches back 2 generations to 1986. 9 later devices descend from it.
- Decided
- Apr 12, 2013
- Review
- 9 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864584 (1986). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK864584 Fluorovision Contrast EnhancerDigivision, Inc. · 1986
- 1 generation backK962260 Real-Time Video Contrast EnhancerDigivision, Inc. · 1996
- This deviceK130929 Zmed VP4000Zmed, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK201434 Connected OR Hub with Voice Control, Connected OR Hub with Device…Stryker · 2020
- Descendant · 2 generations on · 6 of its ownK212055 Connected OR Hub with Device and Voice ControlStryker Corporation · 2021
- Descendant · 3 generations on · 5 of its ownK220108 SDC4K Information Management System with Device and Voice Control…Stryker Endoscopy · 2022
- Descendant · 3 generations on · 4 of its ownK222079 Connected OR Hub with Device and Voice Control, SDC4K Information…Stryker Endoscopy · 2022
- Descendant · 4 generations on · 3 of its ownK230886 Connected OR Hub with Device and Voice Control; SDC4K Information…Stryker Endoscopy · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K201434Connected OR Hub with Voice Control, Connected OR Hub with Device ControlStryker · 2020 · cites it directly8descendants
- K212055Connected OR Hub with Device and Voice ControlStryker Corporation · 2021 · 2 generations on6descendants
- K220108SDC4K Information Management System with Device and Voice Control PackageStryker Endoscopy · 2022 · 3 generations on5descendants
- K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…Stryker Endoscopy · 2022 · 3 generations on4descendants
- K230886Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…Stryker Endoscopy · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864584 | Fluorovision Contrast Enhancer | Digivision, Inc. | 1986 | — |
| −1 | K962260 | Real-Time Video Contrast Enhancer | Digivision, Inc. | 1996 | — |
| 0 (this device) | K130929 | Zmed VP4000 | Zmed, Inc. | 2013 | — |
| +1 | K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device Control | Stryker | 2020 | — |
| +2 | K212055 | Connected OR Hub with Device and Voice Control | Stryker Corporation | 2021 | — |
| +3 | K220108 | SDC4K Information Management System with Device and Voice Control Package | Stryker Endoscopy | 2022 | — |
| +3 | K222079 | Connected OR Hub with Device and Voice Control, SDC4K Information Management… | Stryker Endoscopy | 2022 | — |
| +4 | K230886 | Connected OR Hub with Device and Voice Control; SDC4K Information Management… | Stryker Endoscopy | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K962260 | Real-Time Video Contrast EnhancerSummary page 1…DEVICE NAME: ZMED VP4000 Video Processor PREDICATE DEVICE: DigiVision CE3000 FDA 51 0(k) file #: K962260 Year approved: 1996 DEVICE DESCRIPTION The ZMED VP4000 is a simple-to install, easy to use vi… | 1996 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device Control | 2020 | 8 |
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 27 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201434 (Stryker, 2020) has gone furthest, with 8 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The ZMED VP4000 Video Processor is intended for use in any application where a viewing device (fluoroscope. endloscope, laparoscope, etc.) and monitor are incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130929: Zmed VP4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130929
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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