FDA product code KHP: Acid, Lactic, Enzymatic Method
KHP is the FDA product code for acid, lactic, enzymatic method. It is a Class I device, regulated under 21 CFR 862.1450 and reviewed by the Clinical Chemistry panel. FDA has cleared 27 510(k) submissions under KHP, from 22 different applicants. The average 510(k) review took 121 days (median 76). FDA has posted 19 recalls for KHP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Lactic, Enzymatic Method |
| Device class | Class I |
| Regulation | 21 CFR 862.1450 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KHP clearance
Top KHP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corp. | 2 | 2011-08-17 |
| I-Stat Corp. | 2 | 2001-07-02 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1991-11-27 |
| Eastman Kodak Company | 2 | 1991-08-26 |
| Yellow Springs Instrument Co., Inc. | 2 | 1990-08-27 |
17 more applicants have KHP clearances. See the full list in Caduvo.
Most recent KHP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130113 | Abaxis, Inc. | PICCOLO LACTATE TEST SYSTEM | 2013-03-11 | 54 |
| K113216 | Siemens Healthcare Diagnostics | RAPIDPOINT 500 BLOOD GAS ANALYER | 2012-05-03 | 184 |
| K112955 | Nova Biomedical Corporation | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | 2012-01-05 | 93 |
| K112430 | Abbott Pont of Care, Inc. | I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE | 2011-12-20 | 118 |
| K100602 | Nova Biomedical Corp. | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS | 2011-08-17 | 532 |
Recalls for KHP devices
19 product recalls in 15 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-07-29.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code KHP?
KHP is the FDA product code for acid, lactic, enzymatic method. It is a Class I device, regulated under 21 CFR 862.1450 and reviewed by the Clinical Chemistry panel.
What device class is KHP?
Class I, regulation 21 CFR 862.1450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHP?
Across 27 cleared submissions the average was 121 days from receipt to decision (median 76).
Which companies have the most KHP clearances?
Nova Biomedical Corp. (2); I-Stat Corp. (2); E.I. Dupont DE Nemours & Co., Inc. (2); Eastman Kodak Company (2); Yellow Springs Instrument Co., Inc. (2).
Have KHP devices been recalled?
Yes: 19 product recalls across 15 recall events; the most recent began 2025-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code KHP
- Run a recall and safety report across every KHP manufacturer
- Watch product code KHP 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times