FDA product code LRT: Indicator, Sterilization
LRT is the FDA product code for indicator, sterilization. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under LRT, from 4 different applicants. The average 510(k) review took 264 days (median 270). FDA has posted 1 recall for LRT devices.
Classification
| Field | Value |
|---|---|
| Device name | Indicator, Sterilization |
| Device class | Class II |
| Regulation | 21 CFR 880.2800 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LRT clearance
Top LRT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Albert Browne , Ltd. | 2 | 2001-11-05 |
| Steritec Products Mfg Co, Inc. | 1 | 1996-08-19 |
| Products For Medicine | 1 | 1995-06-28 |
| Propper Mfg. Co., Inc. | 1 | 1987-06-01 |
Most recent LRT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K002937 | Albert Browne , Ltd. | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | 2001-11-05 | 410 |
| K965154 | Albert Browne , Ltd. | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | 1997-09-19 | 270 |
| K951113 | Steritec Products Mfg Co, Inc. | CROSS-CHECKS | 1996-08-19 | 528 |
| K951703 | Products For Medicine | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS | 1995-06-28 | 77 |
| K871672 | Propper Mfg. Co., Inc. | STERILIZATION INDICATOR FOR FLASH STERILIZATION | 1987-06-01 | 34 |
Recalls for LRT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-08-02.
Frequently asked questions
What is FDA product code LRT?
LRT is the FDA product code for indicator, sterilization. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel.
What device class is LRT?
Class II, regulation 21 CFR 880.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code LRT?
Across 5 cleared submissions the average was 264 days from receipt to decision (median 270).
Which companies have the most LRT clearances?
Albert Browne , Ltd. (2); Steritec Products Mfg Co, Inc. (1); Products For Medicine (1); Propper Mfg. Co., Inc. (1).
Have LRT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code LRT
- Run a recall and safety report across every LRT manufacturer
- Watch product code LRT 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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