510(k) Report

510(k) · Cleared

Cleared

Sony PGM-100P1MD Trinitron Color Graphic Monitor

K970999510(k) TraditionalCleared May 20, 199762-day reviewClass II21 CFR 892.1750

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

Sony Medical Systems · JAK System, X-Ray, Tomography, Computed

Cleared on May 20, 1997 as substantially equivalent to K885042 (Sony Medical Electronics Co., 1988) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1988. 39 later devices descend from it.

Decided
May 20, 1997
Review
62 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K885042 (1988). 2 ancestors in all. 39 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1990: 1 other ancestor1998: 5 descendants cleared2004: 2 descendants cleared2005: 2 descendants cleared2002: 2 descendants cleared2006: 2 descendants cleared2013: 4 descendants cleared2007: 3 descendants cleared2011: 4 descendants cleared2008: 5 descendants cleared2010: 2 descendants cleared2015: 3 descendants cleared2012: 1 descendant cleared2014: 2 descendants cleared2020: 1 descendant cleared2021: 1 descendant clearedK885042 · Sony Trinitron Color Video Monitor PVM-1343MD · Sony Medical Electronics Co. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 6 descendants5 generations forward: 10 descendants6 generations forward: 5 descendants7 generations forward: 5 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K885042 · Sony Trinitron Color Video Monitor PVM-1343MD · Sony Medical Electronics Co. · 19880+5
  1. Root · 1 generation backK885042 Sony Trinitron Color Video Monitor PVM-1343MDSony Medical Electronics Co. · 1988
  2. This deviceK970999 Sony PGM-100P1MD Trinitron Color Graphic MonitorSony Medical Systems · 1997
  3. Descendant · cites it directly · 38 of its ownK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
  4. Descendant · cites it directly · 33 of its ownK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
  5. Descendant · 2 generations on · 31 of its ownK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
  6. Descendant · 3 generations on · 15 of its ownK042755 Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005
  7. Descendant · 3 generations on · 14 of its ownK041737 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

1998: 52002: 22004: 22005: 22006: 22007: 32008: 52010: 22011: 42012: 12013: 42014: 22015: 32020: 12021: 1
1998high 5 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 39 · See all
  • K972701Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998 · cites it directly38descendants
  • K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998 · cites it directly33descendants
  • K033859Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004 · 2 generations on31descendants
  • K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005 · 3 generations on15descendants
  • K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K885042Sony Trinitron Color Video Monitor PVM-1343MDSony Medical Electronics Co.1988—
0 (this device)K970999Sony PGM-100P1MD Trinitron Color Graphic MonitorSony Medical Systems1997—
+1K972701Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems1998—
+1K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems1998—
+2K033859Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview2004—
+3K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation2005—
+3K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199850
200220
200420
200520
200620
200730
200850
201020
201140
201210
201340
201420
201530
202010
202110
FIG. 1 — Lineage of K970999, 1988–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 JAK? 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 JAK device

  1. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K885042Sony Trinitron Color Video Monitor PVM-1343MD
Summary page 1
…, Monitoring and Diagnostic Devices Classification Status: Class I 3. Predicate Devices » Sony Trinitron Color Video Momitor PVM-1343MD Sony Medical Systems Division K885042 + Electrohome M1544/1744 High Resolution Monochrome Monitors Electrohome Limited « Siemens Sirecust 1481T Digital Telemetry Sys…
Sony Medical Electronics Co.1988—
*K900319Siemens Sirecust 1481T, Digital Telemetry System
Summary page 1
…d « Siemens Sirecust 1481T Digital Telemetry System (includes the Sony Trinitron® Character Display CPD-1304 as the monitor component) Siemens Medical Electronics, Inc. K900319 Sony PGM-100P1MD Monitor 510(k) 3/18/97 Page D-1 Device Description The Sony PGM-100P1MD Trinitron® Color Graph…
Siemens Medical Electronics1990—
*—Electrohome M1544/1744 High Resolution Monochrome Monitors
Named without a submission number
—

Also cleared against K885042: 4 other devices →

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K972701Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems199838
K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems199833
K983392Data Ray Corporation DR11021 Medical Imaging MonitorData Ray19980

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, K972701 (Barco NV Display Systems, 1998) has gone furthest, with 38 descendants of its own.
  • 4 other devices also cite its predicate K885042.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

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

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

What is it indicated for?

The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended for use in patient monitoring applications to display multi-parameter data in graphic format. The Sony PGM-100P1MD can be used in hospital settings such as the intensive care unit, central station, and nurse station. Applications include the display of data from electrocardiographs, blood pressure and pulse measurement systems, and computed tomography and other imaging systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K885042

4 other devices cite the same predicate.

  • K021456ER150/M2World of Medicine Lemke GmbH · 2002
  • K013709Hill-Rom Primaview Monitor SystemHill-Rom, Inc. · 2001
  • K972701Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
  • K963919Lsi Videoscopic Display SystemLsi Solutions · 1997

More from Sony Medical Systems

6 FDA decisions under this applicant name. See the company

  • K024188UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003
  • K961680Sony DKR-700 Digital Still RecorderSony Medical Systems · 1996
  • K931170Sony Cardiac Analysis and Review Station (Cars)Sony Medical Systems · 1993
  • K924708Cinenet Cardiac Image NetworkSony Medical Systems · 1992
  • K921275Sony Laser Videodisc Recording SystemSony Medical Systems · 1992

Recent decisions in JAK

The JAK category page

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  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K970999 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970999: Sony PGM-100P1MD Trinitron Color Graphic Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970999

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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