510(k) · Cleared
ClearedBasic, Models Basic 1, Basic 2, and Basic 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atys Medical · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 10, 2001 as substantially equivalent to K872517 (D. E. Hokanson, Inc., 1987) and 2 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Aug 10, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K872517 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872517 TL 400 Totalab Vascular Diagnostic SystemD. E. Hokanson, Inc. · 1987
- This deviceK012369 Basic, Models Basic 1, Basic 2, and Basic 3Atys Medical · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872517 | TL 400 Totalab Vascular Diagnostic System | D. E. Hokanson, Inc. | 1987 | — |
| 0 (this device) | K012369 | Basic, Models Basic 1, Basic 2, and Basic 3 | Atys Medical | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K872517 | TL 400 Totalab Vascular Diagnostic SystemSummary page 1…ripheral Doppler with photo & pneumo plethysmography. e Class: Regulatory Class II C. Identification of predicate device Predicate Devices: HOKANSON, TL 400 TOTALAB (K872517). BIOMEDIX, FLOSTAT VASCULAR LAB (K973644) IMEX MEDICAL SYSTEMS, IMEXLAB 9100 (K973562) D. Performance standards Conforms to the… | 1987 |
| * | K973644 | Flostat Vascular LabSummary page 1…hysmography. e Class: Regulatory Class II C. Identification of predicate device Predicate Devices: HOKANSON, TL 400 TOTALAB (K872517). BIOMEDIX, FLOSTAT VASCULAR LAB (K973644) IMEX MEDICAL SYSTEMS, IMEXLAB 9100 (K973562) D. Performance standards Conforms to the following voluntary standards: IEC 601-1,… | 1997 |
| * | K973562 | Imex Medical Systems, Inc. Imexlab 9100Summary page 1…Identification of predicate device Predicate Devices: HOKANSON, TL 400 TOTALAB (K872517). BIOMEDIX, FLOSTAT VASCULAR LAB (K973644) IMEX MEDICAL SYSTEMS, IMEXLAB 9100 (K973562) D. Performance standards Conforms to the following voluntary standards: IEC 601-1, EN 60601-1-2, IEC 801-2,3,4,5 EN55011 (CISP… | 1998 |
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 3 ancestors has a recall.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The BASIC is a non-invasive diagnostic system to assist in the detection of peripheral vascular disease (arterial or venous).
The BASIC is not intended to be used for fetal monitoring nor for fetal applications. The BASIC is not intended for ophthalmic applications.
The BASIC is not intended for home use.
The BASIC is not intended for use on non-intact skin or eyes.
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/K012369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012369: Basic, Models Basic 1, Basic 2, and Basic 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012369
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026