510(k) · Cleared
Cleared1085 Ultimate E Plethysmograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Graphics Corp. · CCM Plethysmograph, Pressure
Cleared on Apr 10, 1995 as substantially equivalent to K852088 (Medical Graphics Corp., 1985) and 1 other predicate after a 278-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Apr 10, 1995
- Review
- 278 days
- Class
- Class II
- Product code
- CCM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852088 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK852088 System 1085 Body PlethysmographMedical Graphics Corp. · 1985
- This deviceK943259 1085 Ultimate E PlethysmographMedical Graphics Corp. · 1995
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852088 | System 1085 Body Plethysmograph | Medical Graphics Corp. | 1985 | — |
| 0 (this device) | K943259 | 1085 Ultimate E Plethysmograph | Medical Graphics Corp. | 1995 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 CCM? 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? (3)
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 |
|---|---|---|---|
| * | K852088 | System 1085 Body PlethysmographSummary page 1…ith EuroPleth option 'nic liardware and software design of the 1085 Ultimate plethysmograph combines two previously c1caredpredicate devices, the 1085 plethysmograph (K852088) and the PF/Dx pulmonary function laboratory (K912906). The consolidation of these two predicate devices combines the separatefea… | 1985 |
| * | K912906 | Medgraphics PF/DXSummary page 1…sign of the 1085 Ultimate plethysmograph combines two previously c1caredpredicate devices, the 1085 plethysmograph (K852088) and the PF/Dx pulmonary function laboratory (K912906). The consolidation of these two predicate devices combines the separatefeatures of each of them, with the exception of portabili… | 1992 |
| * | — | Sensormedics 6200 Autobox DL Automated Body Plethysmograph Named without a submission number |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All CCM devicesCCM Plethysmograph, Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCM
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · CCM
Too few CCM 510(k)s in any year since 2007 to give a median.
Recalls per year · CCM
No recall names CCM since 2007.
Adverse event reports per year · CCM
1in 2023
MAUDE reports naming product code CCM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 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 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
the quantification of lung capacity and function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K943259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943259: 1085 Ultimate E Plethysmograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943259
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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