NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED— 510(k) K142080

Name: FDA 510(k) clearance K142080
Creator: U.S. Food and Drug Administration
Published: 2014-08-28

Substantially Equivalent

Ecolab, Inc.

FDA 510(k) clearance K142080 for NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED, Substantially Equivalent on 2014-08-28. Applicant: Ecolab, Inc.. Device class: 1.

Clearance details

Applicant: Ecolab, Inc.
Product code: Code LHC
Device class: Class 1
Regulation: 21 CFR 890.5950
Advisory panel: Physical Medicine
Date received: 2014-07-31
Decision date: 2014-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHC

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K153713 — Getinge Series Warming Cabinet2016-06-07
K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes2016-01-15
K150190 — IntraTemp Solution Warmer2015-02-26
K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE2014-12-30
K083417 — INTRATEMP SOLUTION WARMER2009-01-13

More clearances from Ecolab, Inc.

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Recalls naming K142080

K-number listed on FDA's recall record

Z-0184-2016 — Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.Class II·Terminated·Resource Optimization & Innovation Llc·20150825
Z-0185-2016 — Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.Class II·Terminated·Resource Optimization & Innovation Llc·20150825
Z-0186-2016 — Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.Class II·Terminated·Resource Optimization & Innovation Llc·20150825
Z-0187-2016 — Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.Class II·Terminated·Resource Optimization & Innovation Llc·20150825
Z-0188-2016 — Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.Class II·Terminated·Resource Optimization & Innovation Llc·20150825
Z-0189-2016 — Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.Class II·Terminated·Resource Optimization & Innovation Llc·20150825
Z-0190-2016 — Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.Class II·Terminated·Resource Optimization & Innovation Llc·20150825
Z-0191-2016 — Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.Class II·Terminated·Resource Optimization & Innovation Llc·20150825
Z-2793-2015 — Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.Class II·Terminated·Ecolab Inc·20150818

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142080.

Data sourced from openFDA. This site is unofficial and independent of the FDA.