510(k) · Cleared
ClearedMedisystems Transducer 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 Nov 25, 1998 as substantially equivalent to K895856 (Medisystems Corp., 1989) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1982. 2 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- FIB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K820459 (1982). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK820459 Viragard/VirashieldTri-Med, Inc. · 1982
- This deviceK983076 Medisystems Transducer ProtectorMedisystems Corp. · 1998
- Descendant · cites it directly · 1 of its ownK072988 Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation · 2008
- Descendant · 2 generations on · 0 of its ownK240164 NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820459 | Viragard/Virashield | Tri-Med, Inc. | 1982 | — |
| 0 (this device) | K983076 | Medisystems Transducer Protector | Medisystems Corp. | 1998 | — |
| +1 | K072988 | Nipro Transducer Protector TP-Sure, Model Tpsure+1 | Nipro Medical Corporation | 2008 | — |
| +2 | K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2024 | 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 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? (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 | Decided |
|---|---|---|---|
| * | K895856 | Medisystems Transducer ProtectorSummary page 1…ch Equivalence is Claimed: The Transducer Protectors that are the subject of this submission are substantially equivalent to those described in Medisystems 510(k) number K895856 for the design and construction of the device and to those described in the Trimed 510(k) number K820459B for the claim of viral… | 1989 |
| * | K820459 | Viragard/VirashieldSummary page 1…ially equivalent to those described in Medisystems 510(k) number K895856 for the design and construction of the device and to those described in the Trimed 510(k) number K820459B for the claim of viral retention. VII. Product Description: Medisystems Transducer Protectors are designed to be used as protec… | 1982 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072988 | Nipro Transducer Protector TP-Sure, Model Tpsure+1 | 2008 | 1 |
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?
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 indicated for use as protective devices for pressure monitors on hemodialysis machines as well as to help protect the sterility of the blood tubing fluid pathway. The filter helps prevent cross-contamination by viruses, bacteria, and other particulate matter while preventing the flow of fluids to the hemodialysis machine’s pressure transducer.
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/K983076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983076: Medisystems Transducer Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983076
Report an extraction error
Are you the manufacturer?
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