510(k) · Cleared
ClearedJamieson Model 2100 Cine Film Processor and Kodak Cineflure Processor Model 2100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jamieson Film Co. · IXX Processor, Cine Film
Cleared on Sep 11, 1996 as substantially equivalent to K913241 (Jamieson Film Co., 1991) after a 16-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 11, 1996
- Review
- 16 days
- Class
- Class II
- Product code
- IXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913241 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913241 Jamieson JT-CRP Cine Film ProcessorJamieson Film Co. · 1991
- This deviceK963334 Jamieson Model 2100 Cine Film Processor and Kodak Cineflure…Jamieson Film Co. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913241 | Jamieson JT-CRP Cine Film Processor | Jamieson Film Co. | 1991 | — |
| 0 (this device) | K963334 | Jamieson Model 2100 Cine Film Processor and Kodak Cineflure Processor Model 2100 | Jamieson Film Co. | 1996 | — |
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 IXX? 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? (1)
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 |
|---|---|---|---|
| * | K913241 | Jamieson JT-CRP Cine Film ProcessorSummary page 1…ographic Film Processor, 21 CFR 892.1900 Predicate Devi The Model 2100 is substantially equivalent to the Jamieson JT/Kodak Ektacath, accepted on September 24, 1991, K# K913241/A. i f the | The Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cinea… | 1991 |
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?
- Its one ancestor has no recall.
How does its category compare?
All IXX devicesIXX Processor, Cine Film: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXX
FDA has decided no IXX device since 2007.
Median 510(k) review, days · IXX
Too few IXX 510(k)s in any year since 2007 to give a median.
Recalls per year · IXX
No recall names IXX since 2007.
Adverse event reports per year · IXX
No MAUDE report names IXX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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 Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cineangiogram films.
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/K963334 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963334: Jamieson Model 2100 Cine Film Processor and Kodak Cineflure Processor Model 2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963334
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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