510(k) · Cleared
ClearedLiquichek Ana Control, Homogeneous Pattern, Model 201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Cleared on Dec 18, 1998 as substantially equivalent to K954276 (Surgical Navigation Technologies, Inc., 1996) and 3 other predicates after a 9-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Dec 18, 1998
- Review
- 9 days
- Class
- Class II
- Product code
- DHN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K905070 (1991). 9 ancestors in all, the oldest K861692 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 3 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 2 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 1 generation backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- This deviceK984398 Liquichek Ana Control, Homogeneous Pattern, Model 201Bio-Rad · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −3 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −2 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −1 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| 0 (this device) | K984398 | Liquichek Ana Control, Homogeneous Pattern, Model 201 | Bio-Rad | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 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 DHN? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954276 | StealthstationSummary page 1…System Common name: Stereotaxic Instrument Classification name: Class II Substantial equivalence claimed to: StealthStation, Surgical Navigation Technologies, Inc., K954276 Radionics Operating Arm & OTS System/StereoPlan, K961844 Picker International Viewpoint System, K970604 Fischer Imaging AutoGuid… | 1996 |
| * | K961844 | Operating Arm System (Oas) [with CT and MR Images]Summary page 1…ion name: Class II Substantial equivalence claimed to: StealthStation, Surgical Navigation Technologies, Inc., K954276 Radionics Operating Arm & OTS System/StereoPlan, K961844 Picker International Viewpoint System, K970604 Fischer Imaging AutoGuide (Part of Mammotest Mammography System), K861692 b S D… | 1996 |
| * | K970604 | Viewpoint - 3.0 SoftwareSummary page 1…med to: StealthStation, Surgical Navigation Technologies, Inc., K954276 Radionics Operating Arm & OTS System/StereoPlan, K961844 Picker International Viewpoint System, K970604 Fischer Imaging AutoGuide (Part of Mammotest Mammography System), K861692 b S Description: The Fluorotactic Guidance System Mk… | 1997 |
| * | K861692 | Fischer PPS/Mammotest Mammography SystemSummary page 1…adionics Operating Arm & OTS System/StereoPlan, K961844 Picker International Viewpoint System, K970604 Fischer Imaging AutoGuide (Part of Mammotest Mammography System), K861692 b S Description: The Fluorotactic Guidance System Mk. I is an intcgrated system that enables a surgeon to more accurately posi… | 1986 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 22 other devices also cite its predicate K954276.
How does its category compare?
All DHN devicesDHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DHN
Too few DHN 510(k)s in any year since 2007 to give a median.
Recalls per year · DHN
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHN
No MAUDE report names DHN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a lincar trajectory insertion or placcment is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle, The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic…
Read the full statement (122 words)
The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a lincar trajectory insertion or placcment is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle,
The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will mave the drill gnide to a precise position.
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/K984398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984398: Liquichek Ana Control, Homogeneous Pattern, Model 201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984398
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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