510(k) Report

FDA applicant

Nipro Medical Corporation

Miami, FL62 decisions1997–202614 recalls

FDA records 62 decisions for Nipro Medical Corporation (Miami, FL) from 1997 to 2026: 62 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and KDI (Dialyzer, High Permeability With Or Without…). Since 2016 its 510(k)s took a median of 246 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 68 predicates, 21 of them its own earlier devices. 14 recalls are linked to its devices.

FDA’s records also spell it “Nipro Medical Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Nipro Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 42008: 22009: 22010: 22012: 62013: 82014: 22016: 12017: 22018: 12019: 32022: 12023: 12026 (partial year): 3
2007high 8 (2013) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2025

2009: 12012: 52013: 12014: 12015: 22017: 12024: 12025: 1
2007high 5 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nipro Medical Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston9decisions
  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System8decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days8decisions
  • FMINeedle, Hypodermic, Single Lumen7decisions
  • FIENeedle, Fistula6decisions
  • FPASet, Administration, Intravascular5decisions

Also: FIB (3), LIT (2), FJK (2), DQX (2), MEB (1), FMG (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 246 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 2 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 68 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 43 times; 21 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072024Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693Nipro Medical Corp. · 20076cite it
  • K030683Nipro Disposable SyringesNipro Medical Corp. · 20034cite it
  • K131935Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation · 20133cite it
  • K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 20053cite it
  • K011297Nipro Safetouch Scalp Vein and Blood Collection SetNipro Medical Corp. · 20013cite it
  • K032777Modification to: Nipro Safe Touch Safety Fistula NeedleNipro Medical Corp. · 20032cite it

What has FDA decided for it lately?

  • K261399Elisio™-HXNipro Medical Corporation · 2026
  • K253047Pressone™Nipro Medical Corporation · 2026
  • K260533Elisio™-HNipro Medical Corporation · 2026
  • K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation · 2023
  • K212677aboNT SYRINGENipro Medical Corporation · 2022
  • K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation · 2019
  • K191359Nipro SyringeNipro Medical Corporation · 2019
  • K182940Surdial DX Hemodialysis SystemNipro Medical Corporation · 20191 recall

All 35 as Nipro Medical Corporation →All 27 as Nipro Medical Corp. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K182940Hemodialysis System, Surdial DX REF: MC+SDX01 Rx OnlyOct 27, 2025Class II
  • K131641Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids…Apr 23, 2024Class II
  • K072024Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is…Dec 19, 2017Class II
  • K071145Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access…Aug 13, 2015Class II
  • K112628NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and…Mar 30, 2015Class II
  • K032777NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.Apr 1, 2014Class III

Other applicant names beginning “Nipro”

FDA records each applicant name separately; these may or may not be the same firm.

Nipro Diabetes Systems, Inc. 5Nipro Diagnostics, Inc. 4Nipro Renal Solutions USA, Corp. 2Nipro Company, Ltd. 1Nipro Technical Solutions, Incoporated 1