510(k) · Cleared

Cleared

Sony Trinitron Color Video Monitor PVM-1343MD

K885042510(k) TraditionalCleared Dec 22, 198817-day reviewClass I21 CFR 878.4160

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

Sony Medical Electronics Co. · KQM Camera, Surgical And Accessories

Cleared on Dec 22, 1988 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.

Decided: Dec 22, 1988
Review: 17 days
Class: Class I
Product code: KQM
Recalls: None
Predicates: 0

43 later devices descend from it, 5 citing it directly.

This deviceK885042 Sony Trinitron Color Video Monitor PVM-1343MDSony Medical Electronics Co. · 1988
Descendant · cites it directly · 39 of its ownK970999 Sony PGM-100P1MD Trinitron Color Graphic MonitorSony Medical Systems · 1997
Descendant · cites it directly · 38 of its ownK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
Descendant · 2 generations on · 33 of its ownK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
Descendant · 3 generations on · 31 of its ownK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
Descendant · 4 generations on · 15 of its ownK042755 Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

1997high 5 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 43 · See all

K970999Sony PGM-100P1MD Trinitron Color Graphic MonitorSony Medical Systems · 1997 · cites it directly39descendants
K972701Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998 · cites it directly38descendants
K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998 · 2 generations on33descendants
K033859Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004 · 3 generations on31descendants
K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005 · 4 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K885042	Sony Trinitron Color Video Monitor PVM-1343MD	Sony Medical Electronics Co.	1988	—
+1	K970999	Sony PGM-100P1MD Trinitron Color Graphic Monitor	Sony Medical Systems	1997	—
+1	K972701	Barco MWD 321 Medical Workstation Display	Barco NV Display Systems	1998	—
+2	K980541	Barco MGD 521 5 Megapixel Diagnostic Display	Barco NV Display Systems	1998	—
+3	K033859	Barcoview MGD 521M Digital Mammography Display	Barco NV Barcoview	2004	—
+4	K042755	Monochrome LCD Monitor, Radiforce G51	Eizo Nanao Corporation	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	5	0
2001	1	0
2002	3	0
2004	2	0
2005	2	0
2006	2	0
2007	3	0
2008	5	0
2010	2	0
2011	4	0
2012	1	0
2013	4	0
2014	2	0
2015	3	0
2020	1	0
2021	1	0

FIG. 1 — Lineage of K885042, 1988–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KQM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (43)

See all 43

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

Number	Device	Applicant	Decided	Descendants
K970999	Sony PGM-100P1MD Trinitron Color Graphic Monitor	Sony Medical Systems	1997	39
K972701	Barco MWD 321 Medical Workstation Display	Barco NV Display Systems	1998	38
K021456	ER150/M2	World of Medicine Lemke GmbH	2002	0
K013709	Hill-Rom Primaview Monitor System	Hill-Rom, Inc.	2001	0
K963919	Lsi Videoscopic Display System	Lsi Solutions	1997	0

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?

Of its descendants, K970999 (Sony Medical Systems, 1997) has gone furthest, with 39 descendants of its own.

How does its category compare?

All KQM devices

KQM Camera, Surgical And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQM

FDA has decided no KQM device since 2007.

Median 510(k) review, days · KQM

Too few KQM 510(k)s in any year since 2007 to give a median.

Recalls per year · KQM

1in 2023

2007high 7 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KQM

9in 2025

2007high 29 (2024) · low 0 (2008)2025

MAUDE reports naming product code KQM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	1
2008	—	0	0
2009	—	0	0
2010	—	7	0
2011	—	0	2
2012	—	0	4
2013	—	0	3
2014	—	0	6
2015	—	1	7
2016	—	0	11
2017	—	0	5
2018	—	0	9
2019	—	0	6
2020	—	0	19
2021	—	0	9
2022	—	0	6
2023	—	1	10
2024	—	0	29
2025	—	0	9
2026	—	0	—

https://510kreport.com/device/K885042 · printed Nov 6, 2026

Cite this page

510(k) Report. “K885042: Sony Trinitron Color Video Monitor PVM-1343MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K885042

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026