510(k) · Cleared
ClearedCodonics NP-1660 Series Medical Printers, Model 1660
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codonics, Inc. · LMC Camera, Multi Format, Radiological
Cleared on Jan 19, 2001 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 19, 2001
- Review
- 71 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK003481 Codonics NP-1660 Series Medical Printers, Model 1660Codonics, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK060440 Codonics Horizon XL Digital Direct Long Film Imager; Codonics…Codonics, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK042232 NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK024188 UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003
- Descendant · 2 generations on · 0 of its ownK111566 Dryview Chroma Imaging SystemCarestream Health, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K021054Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical…Codonics, Inc. · 2002 · cites it directly6descendants
- K060440Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film…Codonics, Inc. · 2006 · 2 generations on1descendant
- K042232NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004 · cites it directly1descendant
- K024188UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003 · 2 generations on1descendant
- K111566Dryview Chroma Imaging SystemCarestream Health, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003481 | Codonics NP-1660 Series Medical Printers, Model 1660 | Codonics, Inc. | 2001 | — |
| +1 | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | Codonics, Inc. | 2002 | — |
| +2 | K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X… | Codonics, Inc. | 2006 | — |
| +1 | K042232 | NP-2600 Series Hardcopy Printers | Codonics, Inc. | 2004 | — |
| +2 | K024188 | UP-DF500 Filmstation Digital Film Imager | Sony Medical Systems | 2003 | — |
| +2 | K111566 | Dryview Chroma Imaging System | Carestream Health, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 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, K021054 (Codonics, Inc., 2002) has gone furthest, with 6 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/K003481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003481: Codonics NP-1660 Series Medical Printers, Model 1660.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003481
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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