FDA product code NJJ: Tonometer, Analyzer, Ocular Blood Flow
NJJ is the FDA product code for tonometer, analyzer, ocular blood flow. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NJJ. The average 510(k) review took 21 days (median 21).
Definition
Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product c lassificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume.
Classification
| Field | Value |
|---|---|
| Device name | Tonometer, Analyzer, Ocular Blood Flow |
| Device class | Class II |
| Regulation | 21 CFR 886.1930 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NJJ clearance
Top NJJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Paradigm Medical Industries, Inc. | 1 | 2002-10-21 |
Most recent NJJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023245 | Paradigm Medical Industries, Inc. | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | 2002-10-21 | 21 |
Recalls for NJJ devices
openFDA lists no recalls for product code NJJ.
Frequently asked questions
What is FDA product code NJJ?
NJJ is the FDA product code for tonometer, analyzer, ocular blood flow. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel.
What device class is NJJ?
Class II, regulation 21 CFR 886.1930. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJJ?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most NJJ clearances?
Paradigm Medical Industries, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJJ
- Run a recall and safety report across every NJJ manufacturer
- Watch product code NJJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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