Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Remel, Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
280 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162620 | Remel Spectra ESBL | Remel, Inc. | 2017-05-01 | 223 | 0 |
| K131804 | REMEL XPECT FLU A&B | Remel, Inc. | 2013-07-12 | 23 | 0 |
| K092407 | REMEL SPECTRA MRSA | Remel, Inc. | 2010-10-08 | 428 | 1 |
| K072827 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | Remel, Inc. | 2007-11-26 | 54 | 0 |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | Remel, Inc. | 2004-11-15 | 118 | 0 |
| K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | Remel, Inc. | 2004-02-26 | 115 | 0 |
| K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | Remel, Inc. | 2003-11-18 | 147 | 0 |
| K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | Remel, Inc. | 2003-11-14 | 141 | 1 |
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | Remel, Inc. | 2003-11-10 | 150 | 1 |
| K031565 | XPECT INFLUENZA A/B | Remel, Inc. | 2003-07-17 | 59 | 0 |
| K981391 | PAR-ONE | Remel, Inc. | 1998-07-14 | 88 | 0 |
| K970832 | PYR SWAB | Remel, Inc. | 1997-04-24 | 48 | 0 |
| K970834 | GRAM SWAB | Remel, Inc. | 1997-04-17 | 41 | 0 |
| K970830 | REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK | Remel, Inc. | 1997-04-02 | 26 | 0 |
| K970833 | INDOLE SWAB | Remel, Inc. | 1997-04-02 | 26 | 0 |
| K970831 | REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK | Remel, Inc. | 1997-04-02 | 26 | 0 |
| K935975 | REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG | Remel, Inc. | 1994-09-19 | 280 | 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