FDA product code LLB: System, Blood, Extracorporeal And Accessories
LLB is the FDA product code for system, blood, extracorporeal and accessories. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under LLB, from 2 different applicants. The average 510(k) review took 224 days (median 224). FDA has posted 1 recall for LLB devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Blood, Extracorporeal And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every LLB clearance
Top LLB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dayspring Medical, Inc. | 1 | 1999-06-22 |
| Gambro, Inc. | 1 | 1984-04-25 |
Most recent LLB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991005 | Dayspring Medical, Inc. | VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS | 1999-06-22 | 89 |
| K831404 | Gambro, Inc. | BLOOD MONITOR BMM 10-4 | 1984-04-25 | 359 |
Recalls for LLB devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-08-13.
Frequently asked questions
What is FDA product code LLB?
LLB is the FDA product code for system, blood, extracorporeal and accessories. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is LLB?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLB?
Across 2 cleared submissions the average was 224 days from receipt to decision (median 224).
Which companies have the most LLB clearances?
Dayspring Medical, Inc. (1); Gambro, Inc. (1).
Have LLB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-08-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LLB
- Run a recall and safety report across every LLB manufacturer
- Watch product code LLB 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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