510(k) · Cleared

Cleared

Head Mounted Display

K961800510(k) TraditionalCleared Sep 11, 1996125-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vista Medical Technologies, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Sep 11, 1996 as substantially equivalent to K923160 (American Surgical Technologies Corp., 1992) and 1 other predicate after a 125-day review. Its family tree reaches back 1 generation to 1992. 6 later devices descend from it.

Decided: Sep 11, 1996
Review: 125 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K923160 (1992). 2 ancestors in all. 6 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
This deviceK961800 Head Mounted DisplayVista Medical Technologies, Inc. · 1996
Descendant · cites it directly · 2 of its ownK030940 Nomad ND1000M Augmented Vision SystemMicrovision Incorporated · 2003
Descendant · cites it directly · 2 of its ownK961343 Medvision Personal MonitorMedvision, Inc. · 1997
Descendant · cites it directly · 1 of its ownK040244 Microoptical's Critical Data Viewers, Models MD-3 and MD-6The Microoptical Corporation · 2004
Descendant · cites it directly · 1 of its ownK981999 Albatech Personal MonitorAlbatech, Inc. · 1998
Descendant · 2 generations on · 0 of its ownK042923 MD-6W Wireless Critical Data ViewerThe Microoptical Corporation · 2004

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997high 2 (2004) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all

K030940Nomad ND1000M Augmented Vision SystemMicrovision Incorporated · 2003 · cites it directly2descendants
K961343Medvision Personal MonitorMedvision, Inc. · 1997 · cites it directly2descendants
K040244Microoptical's Critical Data Viewers, Models MD-3 and MD-6The Microoptical Corporation · 2004 · cites it directly1descendant
K981999Albatech Personal MonitorAlbatech, Inc. · 1998 · cites it directly1descendant
K042923MD-6W Wireless Critical Data ViewerThe Microoptical Corporation · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923160	3DSCOPE	American Surgical Technologies Corp.	1992	—
0 (this device)	K961800	Head Mounted Display	Vista Medical Technologies, Inc.	1996	—
+1	K030940	Nomad ND1000M Augmented Vision System	Microvision Incorporated	2003	—
+1	K961343	Medvision Personal Monitor	Medvision, Inc.	1997	—
+1	K040244	Microoptical's Critical Data Viewers, Models MD-3 and MD-6	The Microoptical Corporation	2004	—
+1	K981999	Albatech Personal Monitor	Albatech, Inc.	1998	—
+2	K042923	MD-6W Wireless Critical Data Viewer	The Microoptical Corporation	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2003	1	0
2004	2	0

FIG. 1 — Lineage of K961800, 1992–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K923160	3DSCOPE Summary page 1 …o System Classification: Camera, Television, Endoscopic, without audio Manufacturer: American Surgical Technologies 300 Billerica Rd ‘ Chelmsford, MA 01824 510(k) #: K923160 -* 2. Device Name: Crystal Eyes View/Record and Playback Controllers with Eyewear and Emitters Classification: Endoscope and Ac…	American Surgical Technologies Corp.	1992	—
*	K944254	Oktas Stereo Viewing System Summary page 1 …rs with Eyewear and Emitters Classification: Endoscope and Accessories, Class II per 21 CFR 876.1500 Manufacturer: Oktas 134 Flanders Rd. Westborough, MA 01581 510(k) #: K944254 DEVICE DESCRIPTION The Head Mounted Display (HMD) System is a binocular field display, occupying a large portion…	Oktas	1994	—

Also cleared against K923160: 3 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030940	Nomad ND1000M Augmented Vision System	Microvision Incorporated	2003	2
K961343	Medvision Personal Monitor	Medvision, Inc.	1997	2
K040244	Microoptical's Critical Data Viewers, Models MD-3 and MD-6	The Microoptical Corporation	2004	1
K981999	Albatech Personal Monitor	Albatech, Inc.	1998	1

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?

None of the 2 ancestors has a recall.
Of its descendants, K030940 (Microvision Incorporated, 2003) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K923160.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)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 Vista Head Mounted Display System is designed to display video images while mounted on the users head.

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/K961800 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961800: Head Mounted Display.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961800

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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