Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MSQ — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
198 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221896 | BreathID Hp System | Meridian Bioscience Israel , Ltd. | 2022-12-19 | 172 | 0 |
| K223185 | BreathID® Smart System | Meridian Bioscience Israel , Ltd. | 2022-11-10 | 29 | 0 |
| K220494 | BreathID Hp Lab System, BreathID Smart System | Meridian Bioscience Israel , Ltd. | 2022-06-23 | 121 | 0 |
| K193610 | BreathID Smart System | Exalenz Bioscience , Ltd. | 2020-02-06 | 42 | 0 |
| K173772 | BreathID Hp System | Exalenz Bioscience , Ltd. | 2018-03-08 | 86 | 0 |
| K173777 | BreathID Hp Lab System | Exalenz Bioscience , Ltd. | 2018-03-08 | 86 | 0 |
| K162150 | BreathID Hp Lab System | Exalenz Bioscience , Ltd. | 2016-10-31 | 90 | 0 |
| K130524 | BREATHID HP SYSTEM | Exalenz Bioscience , Ltd. | 2013-05-22 | 83 | 0 |
| K093834 | CRIT-LINE ANEMIA MANAGEMENT SOFTWARE | Hema Metrics, LLC | 2010-09-29 | 289 | 0 |
| K092817 | POC-AS10 AUTO SAMPLER | Otsuka Pharmaceutical Co., Ltd. | 2010-03-09 | 176 | 0 |
| K041148 | POCONE INFRARED SPECTROPHOTOMETER | Otsuka Pharmaceutical Co., Ltd. | 2004-07-15 | 73 | 0 |
| K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI | Meretek Diagnostics, Inc. | 2002-01-17 | 22 | 1 |
| K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELI | Oridion Medical 1987 , Ltd. | 2001-07-09 | 53 | 0 |
| K000316 | MERETEK UBT_LITE BREATH TEST FOR H. PYLORI | Meretek | 2000-02-24 | 23 | 0 |
| K990931 | EZ-HBT HELICOBACTER BLOOD TEST | Metabolic Solutions, Inc. | 1999-09-24 | 189 | 0 |
| K973000 | ALIMENTERICS LARA (TM) BREATH TEST SYSTEM | Alimenterics, Inc. | 1998-02-26 | 198 | 0 |
| K972352 | THE MERETEK UBT BREATH TEST FOR H.PYLORI | Meretek Diagnostics, Inc. | 1997-10-29 | 127 | 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