510(k) · Cleared
ClearedDrystar 4500 Printer, Model 4500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Medical Imaging · LMC Camera, Multi Format, Radiological
Cleared on Apr 27, 2001 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Apr 27, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK010275 Drystar 4500 Printer, Model 4500Agfa Medical Imaging · 2001
- Descendant · cites it directly · 8 of its ownK012941 Drystar, Model 4500MAgfa Corp. · 2001
- Descendant · 2 generations on · 6 of its ownK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK023287 Drystar 5500Agfa Corp. · 2002
- Descendant · 2 generations on · 1 of its ownK072680 Drystar Axys, Model EYZ4EAgfa Healthcare Corporation · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK060440 Codonics Horizon XL Digital Direct Long Film Imager; Codonics…Codonics, Inc. · 2006
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K012941Drystar, Model 4500MAgfa Corp. · 2001 · cites it directly8descendants
- K021054Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical…Codonics, Inc. · 2002 · 2 generations on6descendants
- K023287Drystar 5500Agfa Corp. · 2002 · cites it directly5descendants
- K072680Drystar Axys, Model EYZ4EAgfa Healthcare Corporation · 2007 · 2 generations on1descendant
- K060440Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film…Codonics, Inc. · 2006 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010275 | Drystar 4500 Printer, Model 4500 | Agfa Medical Imaging | 2001 | — |
| +1 | K012941 | Drystar, Model 4500M | Agfa Corp. | 2001 | — |
| +2 | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | Codonics, Inc. | 2002 | — |
| +1 | K023287 | Drystar 5500 | Agfa Corp. | 2002 | — |
| +2 | K072680 | Drystar Axys, Model EYZ4E | Agfa Healthcare Corporation | 2007 | 1 |
| +3 | K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X… | Codonics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K012941 (Agfa Corp., 2001) has gone furthest, with 8 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 | — |
https://510kreport.com/device/K010275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010275: Drystar 4500 Printer, Model 4500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010275
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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