510(k) · Cleared
ClearedLumax Cystometry Administration Tube Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medamicus, Inc. · FEN Device, Cystometric, Hydraulic
Cleared on Jun 3, 1997 as substantially equivalent to K911865 (North American Sterilization & Packaging Co., 1991) after a 36-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 3, 1997
- Review
- 36 days
- Class
- Class II
- Product code
- FEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911865 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK911865 Nortec Connecting Tube SetNorth American Sterilization & Packaging Co. · 1991
- This deviceK971911 Lumax Cystometry Administration Tube SetMedamicus, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911865 | Nortec Connecting Tube Set | North American Sterilization & Packaging Co. | 1991 | — |
| 0 (this device) | K971911 | Lumax Cystometry Administration Tube Set | Medamicus, Inc. | 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 FEN? 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 FEN device
- #1 K212830 CT3000Proscore 2.8 · 2 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 |
|---|---|---|---|
| * | K911865 | Nortec Connecting Tube SetSummary page 1…tion Intended Use The LuMax Cystometry Tube Set is intended to be used in the exact same manner as the previous tube sets manufactured by NASP and cleared by FDA under K911865/B. The intended use of these tube sets is to provide a conduit from a liquid resevoir to the infusion lumen of a bladder pressure… | 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 FEN devicesFEN Device, Cystometric, Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEN
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · FEN
Too few FEN 510(k)s in any year since 2007 to give a median.
Recalls per year · FEN
No recall names FEN since 2007.
Adverse event reports per year · FEN
3in 2024
MAUDE reports naming product code FEN, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 33 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LuMax Cystometry Tube Set is to be used to provide a conduit from a liquid reservoir to the infusion lumen of a bladder catheter whenever filling a bladder is required in conjunction with performing a Urodynamic Cystometry test.
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/K971911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971911: Lumax Cystometry Administration Tube Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971911
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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