Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectra Medical Devices, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
290 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthes | Spectra Medical Devices, Inc. | 2016-02-05 | 290 | 0 |
| K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE | Spectra Medical Devices, Inc. | 2011-07-29 | 219 | 1 |
| K082689 | STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE | Spectra Medical Devices, Inc. | 2009-03-20 | 186 | 1 |
| K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | Spectra Medical Devices, Inc. | 2008-12-08 | 94 | 0 |
| K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S | Spectra Medical Devices, Inc. | 2008-11-28 | 74 | 0 |
| K081524 | SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, | Spectra Medical Devices, Inc. | 2008-07-29 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda