510(k) · Cleared
ClearedDrystar 5300 Medical Image Printer, Model 5300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corp. · LMC Camera, Multi Format, Radiological
Cleared on Sep 24, 2003 as substantially equivalent to K943602 (Miles Inc., Agfa Division, 1995) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Sep 24, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010275 (2001). 3 ancestors in all, the oldest K943602 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010275 Drystar 4500 Printer, Model 4500Agfa Medical Imaging · 2001
- 1 generation backK023287 Drystar 5500Agfa Corp. · 2002
- This deviceK032635 Drystar 5300 Medical Image Printer, Model 5300Agfa Corp. · 2003
- Descendant · cites it directly · 0 of its ownK061302 Digital Printer P6000D Series, Model P6000DUMitsubishi Electric Corporation Kyoto Works · 2006
Most influential descendants
Showing 1 of 1 · See all- K061302Digital Printer P6000D Series, Model P6000DUMitsubishi Electric Corporation Kyoto Works · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010275 | Drystar 4500 Printer, Model 4500 | Agfa Medical Imaging | 2001 | — |
| −1 | K023287 | Drystar 5500 | Agfa Corp. | 2002 | — |
| 0 (this device) | K032635 | Drystar 5300 Medical Image Printer, Model 5300 | Agfa Corp. | 2003 | — |
| +1 | K061302 | Digital Printer P6000D Series, Model P6000DU | Mitsubishi Electric Corporation Kyoto Works | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 LMC? 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 |
|---|---|---|---|
| * | K943602 | DI-2000Summary page 1…5300 medical printer is substantially equivalent to the Drystar 5500 and Drystar 200013000 printers. The 2000/3000 was cleared for marketing by FDA under K943602 on May 12, 1995, and the 5500 was cleared for marketing under KO23287 on October 22,2002. B. DEVICE DESCRIPTION The… | 1995 |
| * | K023287 | Drystar 5500 | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061302 | Digital Printer P6000D Series, Model P6000DU | 2006 | 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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K061302 (Mitsubishi Electric Corporation Kyoto Works, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMC
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LMC
80in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMC
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMC
2in 2018
MAUDE reports naming product code LMC, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 3 | 80 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Drystar 5300 is a free-standing printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032635: Drystar 5300 Medical Image Printer, Model 5300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032635
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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