510(k) · Cleared

Cleared

Drystar Model 5500

K052251510(k) TraditionalCleared Aug 31, 200513-day reviewClass II21 CFR 892.2040

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

Agfa Corporation · LMC Camera, Multi Format, Radiological

Cleared on Aug 31, 2005 as substantially equivalent to K012941 (Agfa Corp., 2001) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 2000.

Decided: Aug 31, 2005
Review: 13 days
Class: Class II
Product code: LMC
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K002146 (2000). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
1 generation backK012941 Drystar, Model 4500MAgfa Corp. · 2001
This deviceK052251 Drystar Model 5500Agfa Corporation · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002146	Kodak Dryview 8610 Laser Imager / for Mammography	Eastman Kodak Company	2000	—
−1	K012941	Drystar, Model 4500M	Agfa Corp.	2001	—
0 (this device)	K052251	Drystar Model 5500	Agfa Corporation	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0

FIG. 1 — Lineage of K052251, 2000–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K012941	Drystar, Model 4500M Summary page 1 …, SC 29602-9048 Prepared: July 18, 2005 A. Legally Marketed Predicate Devices. The Drystar 4500M printer is legally marketed (cleared) under 510(k) number K01 2941 and the original Drystar 5500 printer was cleared under K023287. The new Drystar 5500, the subject of the present 5 10(k), i…	Agfa Corp.	2001	—
*	K023287	Drystar 5500 Summary page 1 …redicate Devices. The Drystar 4500M printer is legally marketed (cleared) under 510(k) number K01 2941 and the original Drystar 5500 printer was cleared under K023287. The new Drystar 5500, the subject of the present 5 10(k), is very similar to the cleared Drystar 5500 in both hardware…	Agfa Corp.	2002	—

Also cleared against K012941: 2 other devices →

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?

The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K012941.

How does its category compare?

All LMC devices

LMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMC

2in 2014

2007high 3 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMC

80in 2009

2007high 80 (2009)2026

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

Recalls per year · LMC

1in 2008

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LMC

2in 2018

2007high 2 (2018) · low 0 (2007)2025

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 5500M is a free standing device used to print diagnostic conventional and mammography 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/K052251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052251: Drystar Model 5500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052251

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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