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FDA 510(k)

ACDS

K-Number: K120005 · 2012-03-29

ApplicantIsopure, Corp.
Decision Date2012-03-29
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACDS is the device name listed in this FDA 510(k) record. The listed applicant is Isopure, Corp.. It received FDA 510(k) clearance on 2012-03-29 under 510(k) number K120005. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACDS?

ACDS is a medical device that received FDA 510(k) clearance on 2012-03-29. The listed applicant is Isopure, Corp.. The 510(k) number is K120005.

When did ACDS receive FDA 510(k) clearance?

ACDS received FDA 510(k) clearance on 2012-03-29, under 510(k) number K120005.

Who is the listed applicant for ACDS?

The FDA 510(k) record lists Isopure, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACDS?

The FDA product code for ACDS is KPO.

Other records listing Isopure, Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191093Isopure Dry Acid Dissolution SystemK112427BICARB MIXING AND DISTRIBUTION SYSTEMK041163ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIESK993200MD 420/440/460/470/480/490

Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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