510(k) · Cleared
ClearedSony DKR-700 Digital Still Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sony Medical Systems · LMB Device, Digital Image Storage, Radiological
Cleared on Jul 3, 1996 as substantially equivalent to K913886 (Sony Medical Electronics Co., 1992) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jul 3, 1996
- Review
- 63 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913886 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK913886 Sony DVR-10 Digital Videocassette RecorderSony Medical Electronics Co. · 1992
- This deviceK961680 Sony DKR-700 Digital Still RecorderSony Medical Systems · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913886 | Sony DVR-10 Digital Videocassette Recorder | Sony Medical Electronics Co. | 1992 | — |
| 0 (this device) | K961680 | Sony DKR-700 Digital Still Recorder | Sony Medical Systems | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 LMB? 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
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 |
|---|---|---|---|
| * | K913886 | Sony DVR-10 Digital Videocassette RecorderSummary page 2…vices Panel. Sony DKR-700 Recorder 510(k) 4/30/96 Page E-1 Predicate Devices . Sony DVR-10 Digital Videocassette Recorder Sony Medical Systems Division K913886 . Sony Laser VideoDisc Recording (LVR) System Sony LVR-5000A/LVS-5000A Laser VideoDisc Recorder/Processor Sony Medical Systems… | 1992 |
| * | K921275 | Sony Laser Videodisc Recording SystemSummary page 2…edical Systems Division K913886 . Sony Laser VideoDisc Recording (LVR) System Sony LVR-5000A/LVS-5000A Laser VideoDisc Recorder/Processor Sony Medical Systems Division K921275 Device Description The Sony DKR-700 Digital Still Recorder is a general purpose electronic device for digitally recording both… | 1992 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, 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 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sony DKR-700 Digital Still Recorder is intended for use in the recording of video images obtained from medical imaging systems for purposes such as administration, patient record archival storage and education. For example, the DKR-700 Digital Still Recorder can be utilized for recording images acquired by video cameras, fluoroscopic X-ray systems, angiographic X-ray systems, optical microscopes or other systems which produce 3 compatible video signal.
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/K961680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961680: Sony DKR-700 Digital Still Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961680
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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