Product code LDS— General Hospital
CASTLE 7515 UTENSIL/GLASSWARE WASHER
- Classification name
- Device, Pasteurization, Hot Water
- Device class
- Class 2
- Regulation
- 21 CFR 880.6991
- Advisory panel
- General Hospital
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code LDS
FDA has cleared devices under product code LDS between 1981 and 2019, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2019
- 2003
- 2000
- 1997
- 1996
- 1995
- 1989
- 1986
- 1985
- 1981
Top applicants under product code LDS
Recent clearances under product code LDS
- K183444 — Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
- K031799 — MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
- K983068 — RELIANCE FAMILY OF WASHER-DISINFECTORS
- K972193 — OLYMPIX MINI-PASTEURMATIC (58210)
- K950518 — MIELE G 7781 DENTAL THERMAL DISINFECTOR
- K950566 — DECOMAT 4656
- K953645 — OLYMPIC PASTEURMATIC SYSTEM
- K884151 — MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.
- K860263 — CASTLE 7538 FLOOR LOADING WASHER
- K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER
- K810311 — STERI-VERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.