Atlas FDA

STERILE ISOTONIC SALINE & STERILE WATER

FDA 510(k) clearance K954442 · decided 1995-12-21

Clearance details

K-number
K954442
Device name
STERILE ISOTONIC SALINE & STERILE WATER
Applicant
Medcare Custom Packaging, Inc.
Decision
Substantially Equivalent
Date received
1995-09-25
Decision date
1995-12-21
Days to decision
87 days
Clearance type
Traditional
Product code
JOL
Device class
2
Regulation number
880.6740
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
East Swanzey, NH, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medcare Custom Packaging

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 (K051370)Baxter Healthcare Corp2005-08-12
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266)Primary Care Solutions, Inc.2001-07-12
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265)Primary Care Solutions, Inc.2001-07-12
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION (K003402)Welcon, Inc.2001-05-01
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321)Automatic Liquid Packaging, Inc.2000-10-25
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (K974759)Hydrox Laboratories1998-03-09
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (K974758)Hydrox Laboratories1998-03-09
STERILE SALINE FOR CATHETER CARE (K974397)Baxter Healthcare Corp1998-02-10
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (K973734)Welcon, Inc.1998-02-05
GERM TRAPPER SUCTION TUBE HOLDER (K972372)Rzv Medical Specialties, Inc.1997-12-11
CPR SUCTION CATHETER KIT (K960216)Custom Pack Reliability1996-04-15
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (K950201)Sherwood Medical Co.1995-12-15

Recalls involving this device

No recalls on record reference this clearance.