510(k) Report

FDA applicant

Delta Med Spa

Viadana, IT4 decisions2012–202011 recalls

FDA records 4 decisions for Delta Med Spa (Viadana, IT) from 2012 to 2020: 4 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and FPA (Set, Administration, Intravascular). Its devices cite 6 predicates, 1 of them its own earlier devices. 11 recalls are linked to its devices.

FDA’s records also spell it “Delta Med Srl”.

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 Delta Med Spa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12014: 12017: 12020: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

11in 2021

2021: 11
2012high 11 (2021) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Delta Med Spa by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days3decisions
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171530Deltaven XiV Max, Deltaven XiV Max FFDelta Med Spa · 20171cites it

What has FDA decided for it lately?

  • K200373Deltaven Fast Flash Closed I.V. Catheter SystemsDelta Med Spa · 20202 recalls
  • K171530Deltaven XiV Max, Deltaven XiV Max FFDelta Med Spa · 20173 recalls
  • K140175Intravascular Administration SetDelta Med Spa · 2014
  • K121007Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1Delta Med Srl · 20126 recalls

All 3 as Delta Med Spa →The one decision as Delta Med Srl →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K200373DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF…Jun 21, 2021Class II
  • K121007NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522Jun 21, 2021Class II
  • K171530DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072…Jun 21, 2021Class II
  • K121007NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 unitsJun 21, 2021Class II
  • K121007NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122Jun 21, 2021Class II
  • K121007NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822Jun 21, 2021Class II

Other applicant names beginning “Delta”

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

Delta Medical Industries 27Delta Medical Electronics, Inc. 4Delta International Services & Logistics S.R.L 2Delta Marketing, Inc. 1Delta Enterprise Corporation 1Delta Medical Manuf, Inc. 1Delta Industries, Inc. 1Delta Life Science, Inc. 1Delta Surgical Instruments, Inc. 1