510(k) Report

FDA applicant

Spire Biomedical, Inc.

Bedford, MA16 decisions2002–200848 recalls

FDA records 16 decisions for Spire Biomedical, Inc. (Bedford, MA) from 2002 to 2008: 16 510(k) clearances. Most are in product codes MSD (Catheter, Hemodialysis, Implanted) and NFK (Kit, Repair, Catheter, Hemodialysis). Its devices cite 40 predicates, 22 of them its own earlier devices. 48 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Spire Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007: 22008: 2
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

48in 2009

2009: 48
2007high 48 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Spire Biomedical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MSDCatheter, Hemodialysis, Implanted13decisions
  • NFKKit, Repair, Catheter, Hemodialysis2decisions
  • FKADilator, Vessel1decision

Whose devices does it build on?

Its devices cite 40 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 22 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.

  • K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes)Spire Biomedical, Inc. · 20025cite it
  • K013160Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 20025cite it
  • K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSpire Biomedical, Inc. · 20023cite it
  • K06015515.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSpire Biomedical, Inc. · 20063cite it
  • K032061Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH…Spire Biomedical, Inc. · 20033cite it
  • K04285855CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated TipsSpire Biomedical, Inc. · 20041cites it

What has FDA decided for it lately?

  • K073092Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24, DE23SH28, DE27SH32…Spire Biomedical, Inc. · 2008
  • K073093Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32…Spire Biomedical, Inc. · 2008
  • K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40…Spire Biomedical, Inc. · 200748 recalls
  • K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32…Spire Biomedical, Inc. · 200748 recalls
  • K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc. · 2006
  • K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc. · 2006
  • K06015515.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSpire Biomedical, Inc. · 200647 recalls
  • K04285855CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated TipsSpire Biomedical, Inc. · 200448 recalls

All 16 as Spire Biomedical, Inc. →

What has been recalled?

48 recalls linked to its devices; the latest:

  • K03206124CM DECATHLON STD KIT Models: DE19SH24 and DE19SH24-K 15.5 Fr Polyurethane twin lumen…Oct 23, 2009
  • K03206128CM DECATHLON STD KIT Models: DE23SH28 and DE23SH28-K 15.5 Fr Polyurethane twin lumen…Oct 23, 2009
  • K03206132CM DECATHLON STD KIT Models: DE27SH32 and DE27SH32-K 15.5 Fr Polyurethane twin lumen…Oct 23, 2009
  • K03206155CM DECATHLON FUNNEL TIP STD KIT Model: DF50SH55 DECATHLON FUNNEL TIP 15.5 Fr…Oct 23, 2009
  • K03206128CM DECATHLON FUNNEL TIP CATHETER Model: DF23SH28-100 DECATHLON FUNNEL TIP - CATHETER…Oct 23, 2009
  • K03206132CM DECATHLON FUNNEL TIP CATHETER Model: DF27SH32-100 DECATHLON FUNNEL TIP - CATHETER…Oct 23, 2009

Other applicant names beginning “Spire”

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

Spire Medical, Inc. 5Spire, Inc. D/B/A Spire Health 1