510(k) · Cleared
ClearedCybow Reader, Models 300 & 720
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DFI Co., Ltd. · KQO Automated Urinalysis System
Cleared on Aug 9, 2011 as substantially equivalent to K926359 (Heraeus Kulzer, Inc., 1993) after a 371-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 9, 2011
- Review
- 371 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926359 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926359 Clinitek 200+ Urine Chemistry AnalyzerHeraeus Kulzer, Inc. · 1993
- This deviceK102188 Cybow Reader, Models 300 & 720DFI Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926359 | Clinitek 200+ Urine Chemistry Analyzer | Heraeus Kulzer, Inc. | 1993 | — |
| 0 (this device) | K102188 | Cybow Reader, Models 300 & 720 | DFI Co., Ltd. | 2011 | — |
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 KQO? 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? (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 |
|---|---|---|---|
| * | K926359 | Clinitek 200+ Urine Chemistry AnalyzerSummary page 1…sis system Panel: clinical chemistry Product code: KQO, JIL, JIO, 0DM, CEN, JIN, JIR, JJB, JMA, JMT, LJX Predicate Device Information: K926359 / Clinitek 200+, 500 Device Description: CYBOW Reader 300, 720 are reflectance photometer. The strip is illuminated by white li… | 1993 |
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.
- 2 other devices also cite its predicate K926359.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KQO
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KQO
Too few KQO 510(k)s in any year since 2007 to give a median.
Recalls per year · KQO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQO
12in 2025
MAUDE reports naming product code KQO, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 2 | — | 7 | 3 |
| 2011 | 2 | — | 2 | 8 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 1 | 92 |
| 2014 | 1 | — | 0 | 106 |
| 2015 | 2 | — | 0 | 238 |
| 2016 | 0 | — | 1 | 373 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 2 | 64 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semi-automated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quanititatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102188: Cybow Reader, Models 300 & 720.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102188
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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