FDA product code KXF: Applicator, Absorbent Tipped, Non-Sterile
KXF is the FDA product code for applicator, absorbent tipped, non-sterile. It is a Class I device, regulated under 21 CFR 880.6025 and reviewed by the General Hospital panel. FDA has cleared 21 510(k) submissions under KXF, from 16 different applicants. The average 510(k) review took 54 days (median 35). FDA has posted 2 recalls for KXF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Applicator, Absorbent Tipped, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 880.6025 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KXF clearance
Top KXF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smartpractice | 3 | 2012-12-19 |
| Abco Dealers, Inc. | 2 | 1984-10-04 |
| Pollak (Intl.), Ltd. | 2 | 1980-09-16 |
| Dexide, Inc. | 2 | 1979-07-30 |
| Epitest Ltd. OY | 1 | 2002-01-30 |
11 more applicants have KXF clearances. See the full list in Caduvo.
Most recent KXF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123184 | Smartpractice | FINN CHAMBERS AQUA | 2012-12-19 | 70 |
| K103409 | Smartpractice | ALLERGEAZE R CLEAR | 2011-03-15 | 113 |
| K063160 | Smartpractice | ALLERGEAZE PATCH TEST CHAMBERS | 2006-12-22 | 66 |
| K013820 | Epitest Ltd. OY | FINN CHAMBER (R) | 2002-01-30 | 75 |
| K992553 | Dormer Laboratories, Inc. | IQ CHAMBERS | 2000-04-12 | 257 |
Recalls for KXF devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2023-02-03.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code KXF?
KXF is the FDA product code for applicator, absorbent tipped, non-sterile. It is a Class I device, regulated under 21 CFR 880.6025 and reviewed by the General Hospital panel.
What device class is KXF?
Class I, regulation 21 CFR 880.6025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KXF?
Across 21 cleared submissions the average was 54 days from receipt to decision (median 35).
Which companies have the most KXF clearances?
Smartpractice (3); Abco Dealers, Inc. (2); Pollak (Intl.), Ltd. (2); Dexide, Inc. (2); Epitest Ltd. OY (1).
Have KXF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code KXF
- Run a recall and safety report across every KXF manufacturer
- Watch product code KXF 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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