FDA product code KIE: Apparatus, High Pressure Liquid Chromatography
KIE is the FDA product code for apparatus, high pressure liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel. FDA has cleared 25 510(k) submissions under KIE, from 11 different applicants. The average 510(k) review took 49 days (median 35). FDA has posted 2 recalls for KIE devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, High Pressure Liquid Chromatography |
| Device class | Class I |
| Regulation | 21 CFR 862.2260 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIE clearance
Top KIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hewlett-Packard Co. | 4 | 1980-03-25 |
| Laboratory Data Control | 4 | 1980-02-26 |
| Waters Assoc., Inc. | 4 | 1979-09-24 |
| The Perkin-Elmer Corp. | 3 | 1994-04-26 |
| Millipore Corp. | 3 | 1992-12-11 |
6 more applicants have KIE clearances. See the full list in Caduvo.
Most recent KIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964588 | Waters Corporation | WATERS 515 HPLC PUMP (515) | 1996-11-29 | 14 |
| K935666 | The Perkin-Elmer Corp. | PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP | 1994-04-26 | 151 |
| K924347 | Millipore Corp. | WATERS(TM) 996 PDA | 1992-12-11 | 106 |
| K914841 | Millipore Corp. | CHROMATOGRAPHY CLINICAL USE 75JQR | 1991-12-10 | 46 |
| K911299 | Rohm and Haas Co. | EQUIPMENT/MATERIAL DECONTAMINATING KIT | 1991-04-08 | 14 |
Recalls for KIE devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-10-09.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code KIE?
KIE is the FDA product code for apparatus, high pressure liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel.
What device class is KIE?
Class I, regulation 21 CFR 862.2260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIE?
Across 25 cleared submissions the average was 49 days from receipt to decision (median 35).
Which companies have the most KIE clearances?
Hewlett-Packard Co. (4); Laboratory Data Control (4); Waters Assoc., Inc. (4); The Perkin-Elmer Corp. (3); Millipore Corp. (3).
Have KIE devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-10-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KIE
- Run a recall and safety report across every KIE manufacturer
- Watch product code KIE 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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