FDA product code LDS: Device, Pasteurization, Hot Water
LDS is the FDA product code for device, pasteurization, hot water. It is a Class II device, regulated under 21 CFR 880.6991 and reviewed by the General Hospital panel. FDA has cleared 11 510(k) submissions under LDS, from 9 different applicants. The average 510(k) review took 202 days (median 155). FDA has posted 11 recalls for LDS devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Pasteurization, Hot Water |
| Device class | Class II |
| Regulation | 21 CFR 880.6991 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for LDS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 271 |
Compare with all 510(k) review times · Search every LDS clearance
Top LDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympic Medical Corp. | 2 | 1997-09-05 |
| Castle Co. | 2 | 1986-03-05 |
| Cenorin, LLC | 1 | 2019-09-09 |
| Miele, Inc. | 1 | 2003-11-12 |
| STERIS Corporation | 1 | 2000-05-31 |
4 more applicants have LDS clearances. See the full list in Caduvo.
Most recent LDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183444 | Cenorin, LLC | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector | 2019-09-09 | 271 |
| K031799 | Miele, Inc. | MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 | 2003-11-12 | 155 |
| K983068 | STERIS Corporation | RELIANCE FAMILY OF WASHER-DISINFECTORS | 2000-05-31 | 637 |
| K972193 | Olympic Medical Corp. | OLYMPIX MINI-PASTEURMATIC (58210) | 1997-09-05 | 87 |
| K950518 | Miele Professional | MIELE G 7781 DENTAL THERMAL DISINFECTOR | 1996-01-26 | 354 |
Recalls for LDS devices
11 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-04-09.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code LDS?
LDS is the FDA product code for device, pasteurization, hot water. It is a Class II device, regulated under 21 CFR 880.6991 and reviewed by the General Hospital panel.
What device class is LDS?
Class II, regulation 21 CFR 880.6991. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDS?
Across 11 cleared submissions the average was 202 days from receipt to decision (median 155).
Which companies have the most LDS clearances?
Olympic Medical Corp. (2); Castle Co. (2); Cenorin, LLC (1); Miele, Inc. (1); STERIS Corporation (1).
Have LDS devices been recalled?
Yes: 11 product recalls across 6 recall events; the most recent began 2018-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LDS
- Run a recall and safety report across every LDS manufacturer
- Watch product code LDS 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times