510(k) · Cleared
ClearedByron Medical Aspiration and Infiltration/Irrigation Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byron Medical · KGZ Accessories, Catheter
Cleared on Feb 10, 1998 as substantially equivalent to K923201 (Armm, Inc., 1993) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Feb 10, 1998
- Review
- 88 days
- Class
- Class I
- Product code
- KGZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K820937 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK820937 Ackrad Fluid Connecting SetAckrad Laboratories · 1982
- This deviceK974295 Byron Medical Aspiration and Infiltration/Irrigation TubingByron Medical · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820937 | Ackrad Fluid Connecting Set | Ackrad Laboratories | 1982 | — |
| 0 (this device) | K974295 | Byron Medical Aspiration and Infiltration/Irrigation Tubing | Byron Medical | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 KGZ? 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K93482 | VCI Suction and Irrigation Tubing Sets Number could not be read Summary page 2…to be substantially equivalent to pre-amendment devices as outlined below. Product: VCI Suction and Irrigation Tubing Sets Manufacturer: Vital Concepts 510(k) Number: K93482 Substantial Equivalence Date: 01 February 1994 Product: Irrigation and Aspiration Tubing Manufacturer: ARMM, Inc. 510(k) Numbe… | |
| * | K923201 | Endosi Suction IrrigatorSummary page 2…Vital Concepts 510(k) Number: K93482 Substantial Equivalence Date: 01 February 1994 Product: Irrigation and Aspiration Tubing Manufacturer: ARMM, Inc. 510(k) Number: K923201 Substantial Equivalence Date: Unknown Product: Ackrad Fluid Connecting Set Manufacturer: Ackrad Laboratories, Inc. 510(k) Numb… | 1993 |
| * | K820937 | Ackrad Fluid Connecting SetSummary page 2…: ARMM, Inc. 510(k) Number: K923201 Substantial Equivalence Date: Unknown Product: Ackrad Fluid Connecting Set Manufacturer: Ackrad Laboratories, Inc. 510(k) Number: K820937 Substantial Equivalence Date: 26 April 1982 Substantial Equivalence Letter is presented as Exhibit N. Product: Disposable Tubi… | 1982 |
| * | — | Disposable Tubing 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.
- 1 other device also cites its predicate K923201.
How does its category compare?
All KGZ devicesKGZ Accessories, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGZ
FDA has decided no KGZ device since 2007.
Median 510(k) review, days · KGZ
Too few KGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · KGZ
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGZ
30in 2025
MAUDE reports naming product code KGZ, 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 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 4 | 7 |
| 2010 | 0 | — | 2 | 37 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 54 |
| 2017 | 0 | — | 0 | 78 |
| 2018 | 0 | — | 0 | 100 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 0 | — | 1 | 113 |
| 2021 | 0 | — | 0 | 36 |
| 2022 | 0 | — | 0 | 88 |
| 2023 | 0 | — | 0 | 55 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 3 | 30 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Tubing Indications for use are general surgical fluid, exudate,
and soft tissue aspiration and general surgical fluid
irrigation/infiltration.
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/K974295 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974295: Byron Medical Aspiration and Infiltration/Irrigation Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974295
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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