510(k) · Cleared
ClearedBlood Flow Analyzer (Bfa), Model 408-100-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Medical Industries, Inc. · NJJ Tonometer, Analyzer, Ocular Blood Flow
Cleared on Oct 21, 2002 as substantially equivalent to K970887 (Paradigm Medical Industries, Inc., 1997) after a 21-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Oct 21, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- NJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K873422 (1987). No later device cites it as a predicate yet.
- Root · 2 generations backK873422 Obf Model 115 Computer Tonometer SystemOcular Blood Flow Laboratories, Inc. · 1987
- 1 generation backK970887 Blood Flow AnalyzerParadigm Medical Industries, Inc. · 1997
- This deviceK023245 Blood Flow Analyzer (Bfa), Model 408-100-01Paradigm Medical Industries, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873422 | Obf Model 115 Computer Tonometer System | Ocular Blood Flow Laboratories, Inc. | 1987 | — |
| −1 | K970887 | Blood Flow Analyzer | Paradigm Medical Industries, Inc. | 1997 | — |
| 0 (this device) | K023245 | Blood Flow Analyzer (Bfa), Model 408-100-01 | Paradigm Medical Industries, Inc. | 2002 | — |
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 NJJ? 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 |
|---|---|---|---|
| * | K970887 | Blood Flow AnalyzerSummary page 1…assification Name: 886.1930 - Tonometer, AC Powered Product Code: 86 NJJ - Tonometer, Analyzer, Ocular Blood Flow Legally Marketed Predicate Device: K970887, Blood Flow Analyzer (BFA), Paradigm Medical Industries, Inc. Establishment Registration Number: 1722205 Description of Devic… | 1997 |
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 15 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NJJ devicesNJJ Tonometer, Analyzer, Ocular Blood Flow: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NJJ
FDA has decided no NJJ device since 2007.
Median 510(k) review, days · NJJ
Too few NJJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NJJ
No recall names NJJ since 2007.
Adverse event reports per year · NJJ
No MAUDE report names NJJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Tonometry for Measuring and Recording Intraocular Pressures and Intraocular Pressure Pulse Amplitudes
Pulsatile Ocular Blood Flow
Pulsatile Ocular Blood Volume
Pulsatility Equivalence Index (PEQ)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023245: Blood Flow Analyzer (Bfa), Model 408-100-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023245
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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