510(k) · Cleared
ClearedEnview (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 2200 · OCV Endoscope Holder
Cleared on Dec 2, 2010 as substantially equivalent to K093616 (Carefusion 2200, 2009) and 1 other predicate after a 121-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Dec 2, 2010
- Review
- 121 days
- Class
- Class II
- Product code
- OCV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931783 (1993). 16 ancestors in all, the oldest K922626 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 5 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- 4 generations backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- 3 generations backK023735 Lapman Laparoscope Manipulator System and Accessories, Model 900-001Medsys, S.A. · 2003
- 2 generations backK043284 EndoassistArmstrong Healthcare Limited · 2005
- 1 generation backK090340 FreehandProsurgics Limited · 2009
- This deviceK102179 Enview (TM)Carefusion 2200 · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −6 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −5 | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| −4 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| −3 | K023735 | Lapman Laparoscope Manipulator System and Accessories, Model 900-001 | Medsys, S.A. | 2003 | — |
| −2 | K043284 | Endoassist | Armstrong Healthcare Limited | 2005 | — |
| −1 | K090340 | Freehand | Prosurgics Limited | 2009 | — |
| 0 (this device) | K102179 | Enview (TM) | Carefusion 2200 | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 OCV? 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 OCV device
- #1 K240506 KARL STORZ Holdersscore 9.4 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K093616 | V. Mueller Camera Controller with Storage CartSummary page 1…78 OCV, Endoscope Holder and Accessories 21 CFR §876.1500 Class: 1I Predicate Devices: V.Mueller Camera Controller with Storage Cart, K093616 Prosurgics Freehand, K090340 Intended Use: The EnViewT camera controller is intended for use by… | 2009 |
| * | K090340 | FreehandSummary page 1…21 CFR §876.1500 Class: 1I Predicate Devices: V.Mueller Camera Controller with Storage Cart, K093616 Prosurgics Freehand, K090340 Intended Use: The EnViewT camera controller is intended for use by surgeons and their designees to hold… | 2009 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All OCV devicesOCV Endoscope Holder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OCV
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCV
Too few OCV 510(k)s in any year since 2007 to give a median.
Recalls per year · OCV
No recall names OCV since 2007.
Adverse event reports per year · OCV
1in 2025
MAUDE reports naming product code OCV, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EnViewTM camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures.
A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemnicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102179: Enview (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102179
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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