# Spire Biomedical, Inc.

- Location (FDA's records): Bedford, MA
- FDA decisions: 16 (2002–2008): 16 510(k) clearances
- Product codes: MSD (13), NFK (2), FKA (1)
- Predicates its devices cite: 40 (22 its own); citations of its devices by later devices: 23 (22 its own)
- Recalls linked to its devices: 48 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Vascular: 7 (https://510kreport.com/company/medtronic-vascular)
- Diametrics Medical, Inc.: 3 (https://510kreport.com/company/diametrics-medical)
- Kendall: 2 (https://510kreport.com/company/kendall)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)
- Electro-Biology, Inc.: 1 (https://510kreport.com/company/electro-biology)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Med-Conduit, Inc.: 1 (https://510kreport.com/company/med-conduit)

## Its most-cited devices
- K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes) (2002), cited by 5
- K013160: Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter (2002), cited by 5
- K021212: 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (2002), cited by 3
- K060155: 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (2006), cited by 3
- K032061: Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH (2003), cited by 3
- K042858: 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips (2004), cited by 1

## Recent decisions
- K073092: Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, (Jan 29, 2008)
- K073093: Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, (Jan 22, 2008)
- K063441: 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 (Feb 12, 2007)
- K063431: 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 (Jan 29, 2007)
- K062435: Repair Kit for Xpresso, Decathlon, and Alta LR Catheters (Dec 5, 2006)
- K060288: Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters (Sep 1, 2006)
- K060155: 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (May 9, 2006)
- K042858: 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips (Dec 3, 2004)

Source page: https://510kreport.com/company/spire-biomedical