510(k) · Cleared
ClearedBlood Flow Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Medical Industries, Inc. · HKY Tonometer, Manual
Cleared on Jun 17, 1997 as substantially equivalent to K873422 (Ocular Blood Flow Laboratories, Inc., 1987) after a 98-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Jun 17, 1997
- Review
- 98 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K873422 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK873422 Obf Model 115 Computer Tonometer SystemOcular Blood Flow Laboratories, Inc. · 1987
- This deviceK970887 Blood Flow AnalyzerParadigm Medical Industries, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK023245 Blood Flow Analyzer (Bfa), Model 408-100-01Paradigm Medical Industries, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K023245Blood Flow Analyzer (Bfa), Model 408-100-01Paradigm Medical Industries, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873422 | Obf Model 115 Computer Tonometer System | Ocular Blood Flow Laboratories, Inc. | 1987 | — |
| 0 (this device) | K970887 | Blood Flow Analyzer | Paradigm Medical Industries, Inc. | 1997 | — |
| +1 | K023245 | Blood Flow Analyzer (Bfa), Model 408-100-01 | Paradigm Medical Industries, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 HKY? 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 HKY device
- #1 K241447 iCare ST500 (TA04)score 9.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K873422 | Obf Model 115 Computer Tonometer SystemSummary page 1…er e Common Name - Tonometer and Accessories e Classification Name - Tonometer and Accessories Ocular Blood Flow Laboratories (OBF) Model 115 Computer Tonometer System (K873422, SE date 11/02/87) The OBF Labs’ device was found equivalent to the Digilab OCVM- Ocular Cerebral Vascular Monitor manufactured… | 1987 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023245 | Blood Flow Analyzer (Bfa), Model 408-100-01 | 2002 | 0 |
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.
- Of its descendants, K023245 (Paradigm Medical Industries, Inc., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HKY
128in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKY
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKY
1in 2019
MAUDE reports naming product code HKY, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 3 | 123 | 2 | 3 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 226 | 0 | 2 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 77 | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 128 | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.
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/K970887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970887: Blood Flow Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970887
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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