FDA product code LLK: Legging, Compression, Non-Inflatable
LLK is the FDA product code for legging, compression, non-inflatable. It is a Class II device, regulated under 21 CFR 880.5780 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under LLK, from 4 different applicants. The average 510(k) review took 84 days (median 84). FDA has posted 1 recall for LLK devices.
Classification
| Field | Value |
|---|---|
| Device name | Legging, Compression, Non-Inflatable |
| Device class | Class II |
| Regulation | 21 CFR 880.5780 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LLK clearance
Top LLK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aci Medical, Inc. | 1 | 1990-11-02 |
| Tecnol New Jersey Wound Care, Inc. | 1 | 1987-12-11 |
| A-T Surgical Mfg. Co., Inc. | 1 | 1987-08-04 |
| Spacelabs, Inc. | 1 | 1984-02-13 |
Most recent LLK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903532 | Aci Medical, Inc. | UNNA-SLEEVE(TM) | 1990-11-02 | 88 |
| K873368 | Tecnol New Jersey Wound Care, Inc. | TECNOL COMPRESSION KNEE DRESSING | 1987-12-11 | 112 |
| K871889 | A-T Surgical Mfg. Co., Inc. | COMPRESSION LEGGING DEVICE | 1987-08-04 | 81 |
| K834460 | Spacelabs, Inc. | MODEL 1888 ALPHA COS/RESPIRATION CAR | 1984-02-13 | 56 |
Recalls for LLK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-10-08.
Frequently asked questions
What is FDA product code LLK?
LLK is the FDA product code for legging, compression, non-inflatable. It is a Class II device, regulated under 21 CFR 880.5780 and reviewed by the General Hospital panel.
What device class is LLK?
Class II, regulation 21 CFR 880.5780. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LLK?
Across 4 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most LLK clearances?
Aci Medical, Inc. (1); Tecnol New Jersey Wound Care, Inc. (1); A-T Surgical Mfg. Co., Inc. (1); Spacelabs, Inc. (1).
Have LLK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-10-08.
Next steps
- Run an FDA pathway report with predicate devices for product code LLK
- Run a recall and safety report across every LLK manufacturer
- Watch product code LLK 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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