FDA product code LKB: Pad, Alcohol, Device Disinfectant
LKB is the FDA product code for pad, alcohol, device disinfectant. It is a Unclassified device, reviewed by the General Hospital panel. FDA has cleared 25 510(k) submissions under LKB, from 18 different applicants. The average 510(k) review took 97 days (median 68). FDA has posted 9 recalls for LKB devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pad, Alcohol, Device Disinfectant |
| Device class | Unclassified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LKB clearance
Top LKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aplicare, Inc. | 4 | 1983-10-31 |
| Span-America Medical Systems, Inc. | 3 | 1989-10-03 |
| Concord Laboratories, Inc. | 3 | 1989-05-16 |
| Professional Disposables International, Inc. | 1 | 2014-08-27 |
| Becton, Dickinson & CO | 1 | 2013-03-20 |
13 more applicants have LKB clearances. See the full list in Caduvo.
Most recent LKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132380 | Professional Disposables International, Inc. | PREVANTICS DEVICE SWAB | 2014-08-27 | 392 |
| K121655 | Becton, Dickinson & CO | BD ALCOHOL SWAB | 2013-03-20 | 288 |
| K112791 | C. R. Bard | SITESCRUB IPA DEVICE | 2012-02-24 | 151 |
| K912161 | Medical Device Inspection Co., Inc. | I.V. STARR KIT | 1991-10-08 | 145 |
| K912731 | Westlock Investments (Usa), Inc. | STERI-SWAB | 1991-10-02 | 104 |
Recalls for LKB devices
9 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-02-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code LKB?
LKB is the FDA product code for pad, alcohol, device disinfectant. It is a Unclassified device, reviewed by the General Hospital panel.
What device class is LKB?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LKB?
Across 25 cleared submissions the average was 97 days from receipt to decision (median 68).
Which companies have the most LKB clearances?
Aplicare, Inc. (4); Span-America Medical Systems, Inc. (3); Concord Laboratories, Inc. (3); Professional Disposables International, Inc. (1); Becton, Dickinson & CO (1).
Have LKB devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2024-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code LKB
- Run a recall and safety report across every LKB manufacturer
- Watch product code LKB 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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