FDA product code GLY: Oximeter To Measure Hemoglobin
GLY is the FDA product code for oximeter to measure hemoglobin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. FDA has cleared 5 510(k) submissions under GLY, from 4 different applicants. The average 510(k) review took 136 days (median 122).
Classification
| Field | Value |
|---|---|
| Device name | Oximeter To Measure Hemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7500 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GLY clearance
Top GLY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corp. | 2 | 1999-12-02 |
| Nir Diagnostics, Inc. | 1 | 2005-05-05 |
| Radiometer America, Inc. | 1 | 1996-02-20 |
| Avl Scientific Corp. | 1 | 1989-11-06 |
Most recent GLY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050014 | Nir Diagnostics, Inc. | HEMONIR TM | 2005-05-05 | 122 |
| K993104 | Nova Biomedical Corp. | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR | 1999-12-02 | 77 |
| K955013 | Nova Biomedical Corp. | NOVA CO-OXIMETER ANALYZER | 1996-04-25 | 176 |
| K952725 | Radiometer America, Inc. | MULTICHECK | 1996-02-20 | 251 |
| K895466 | Avl Scientific Corp. | AVL MODEL 912 CO-OXYLITE | 1989-11-06 | 56 |
Recalls for GLY devices
openFDA lists no recalls for product code GLY.
Frequently asked questions
What is FDA product code GLY?
GLY is the FDA product code for oximeter to measure hemoglobin. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is GLY?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GLY?
Across 5 cleared submissions the average was 136 days from receipt to decision (median 122).
Which companies have the most GLY clearances?
Nova Biomedical Corp. (2); Nir Diagnostics, Inc. (1); Radiometer America, Inc. (1); Avl Scientific Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GLY
- Run a recall and safety report across every GLY manufacturer
- Watch product code GLY 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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