510(k) · Cleared
ClearedHCL - 200 Biochemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hcl Laboratory Systems, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use
Cleared on Jan 22, 1997 as substantially equivalent to K851172 (Roche Diagnostic Systems, Inc., 1985) after a 79-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jan 22, 1997
- Review
- 79 days
- Class
- Class I
- Product code
- JJF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851172 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK851172 Cobas MiraRoche Diagnostic Systems, Inc. · 1985
- This deviceK964409 HCL - 200 Biochemistry AnalyzerHcl Laboratory Systems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851172 | Cobas Mira | Roche Diagnostic Systems, Inc. | 1985 | — |
| 0 (this device) | K964409 | HCL - 200 Biochemistry Analyzer | Hcl Laboratory Systems, 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 JJF? 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 |
|---|---|---|---|
| * | K851172 | Cobas MiraSummary page 1…itro diagnostic multichannel chemistry analyzer. Technological Characteristics Compared to the Predicate Device The functions of the HCL-200 and the COBAS MIRA [510 (k) K851172] are fundamentally the same. The basic physical principles for measurement of radiant energy, absorbed or transmitted, under con… | 1985 |
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 K851172.
How does its category compare?
All JJF devicesJJF Analyzer, Chemistry, Micro, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJF
FDA has decided no JJF device since 2007.
Median 510(k) review, days · JJF
Too few JJF 510(k)s in any year since 2007 to give a median.
Recalls per year · JJF
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJF
2in 2025
MAUDE reports naming product code JJF, 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 | — | 2 | 10 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 21 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 3 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.
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/K964409 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964409: HCL - 200 Biochemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964409
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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