510(k) · Cleared
ClearedMedisystems Tranducer Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisystems Corp. · FIB Protector, Transducer, Dialysis
Cleared on May 12, 1997 as substantially equivalent to K895856 (Medisystems Corp., 1989) after an 89-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- May 12, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- FIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895856 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK895856 Medisystems Transducer ProtectorMedisystems Corp. · 1989
- This deviceK970536 Medisystems Tranducer ProtectorMedisystems Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895856 | Medisystems Transducer Protector | Medisystems Corp. | 1989 | — |
| 0 (this device) | K970536 | Medisystems Tranducer Protector | Medisystems Corp. | 1997 | — |
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 FIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FIB device
- #1 K240164 NovaLine SP-C35 Transducer Protector (956007)score 8.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K895856 | Medisystems Transducer ProtectorSummary page 1…Equivalence is Claimed: The Transducer Protectors which are the subject of this submission are substantially equivalent to those described in Medisystems’ 510(k) number K895856. VII. Product Description: Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors… | 1989 |
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.
- 1 other device also cites its predicate K895856.
How does its category compare?
All FIB devicesFIB Protector, Transducer, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FIB
Too few FIB 510(k)s in any year since 2007 to give a median.
Recalls per year · FIB
No recall names FIB since 2007.
Adverse event reports per year · FIB
2in 2017
MAUDE reports naming product code FIB, 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 | 1 | — | 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 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 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 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway.
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/K970536 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970536: Medisystems Tranducer Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970536
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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