Spire Biomedical, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Spire Biomedical, Inc.” (first 2002, latest 2008), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | 13 | 13 |
| NFK | Kit, Repair, Catheter, Hemodialysis | 2 | 2 |
| FKA | Dilator, Vessel | 1 | 1 |
Review panels
Most recent Spire Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073092 | DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, | MSD | 2008-01-29 | 89 |
| K073093 | DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, | MSD | 2008-01-22 | 82 |
| K063441 | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 | MSD | 2007-02-12 | 90 |
| K063431 | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 | MSD | 2007-01-29 | 77 |
| K062435 | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS | NFK | 2006-12-05 | 106 |
| K060288 | RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS | MSD | 2006-09-01 | 207 |
| K060155 | 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS | MSD | 2006-05-09 | 109 |
| K042858 | 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS | MSD | 2004-12-03 | 49 |
| K041559 | 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 | MSD | 2004-07-30 | 50 |
| K040509 | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 | MSD | 2004-04-19 | 52 |
6 earlier clearances. See the full list in Caduvo.
Recalls
48 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-10-23.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Spire Medical, Inc. (5 510(k)s)
- Spire, Inc. D/B/A Spire Health (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spire Biomedical, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Spire Biomedical, Inc.” (first 2002, latest 2008), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spire Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spire Biomedical, Inc. is 86 days.
Which FDA product codes appear under Spire Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are MSD (Catheter, Hemodialysis, Implanted, 13); NFK (Kit, Repair, Catheter, Hemodialysis, 2); FKA (Dilator, Vessel, 1).
Next steps
- See all 16 Spire Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MSD, Spire Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.