FDA product code LZF: Pump, Infusion, Analytical Sampling
LZF is the FDA product code for pump, infusion, analytical sampling. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under LZF, from 5 different applicants. The average 510(k) review took 361 days (median 320). FDA has posted 1 recall for LZF devices.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Analytical Sampling |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for LZF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 448 |
| 2020 | 1 | 128 |
Compare with all 510(k) review times · Search every LZF clearance
Top LZF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Via Medical Corp. | 3 | 1996-02-28 |
| Optiscan Biomedical Corporation | 1 | 2020-02-05 |
| Optiscan Biomedical Corp. | 1 | 2017-10-16 |
| Metracor Technologies, Inc. | 1 | 2002-01-08 |
| Pemlab Corp. | 1 | 1988-12-30 |
Most recent LZF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192785 | Optiscan Biomedical Corporation | OptiScanner® 5000 Glucose Monitoring System | 2020-02-05 | 128 |
| K162042 | Optiscan Biomedical Corp. | OptiScanner 5000 Glucose Monitoring System | 2017-10-16 | 448 |
| K011238 | Metracor Technologies, Inc. | RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM | 2002-01-08 | 260 |
| K951739 | Via Medical Corp. | PUMP/BLOOD CHEMISTRY MONITOR | 1996-02-28 | 320 |
| K922997 | Via Medical Corp. | VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. | 1994-01-11 | 568 |
Recalls for LZF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-24.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4220 — Refill kit for implantable infusion pump
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
Frequently asked questions
What is FDA product code LZF?
LZF is the FDA product code for pump, infusion, analytical sampling. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the Clinical Chemistry panel.
What device class is LZF?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZF?
Across 7 cleared submissions the average was 361 days from receipt to decision (median 320).
Which companies have the most LZF clearances?
Via Medical Corp. (3); Optiscan Biomedical Corporation (1); Optiscan Biomedical Corp. (1); Metracor Technologies, Inc. (1); Pemlab Corp. (1).
Have LZF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-05-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LZF
- Run a recall and safety report across every LZF manufacturer
- Watch product code LZF 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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