Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Health & Life Co., Ltd. — Predicate Candidate Screening
60 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
170 days90th percentile
60clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211744 | Non-Contact Infrared Thermometer, model HL710H | Health & Life Co., Ltd. | 2021-11-24 | 170 | 0 |
| K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM | Health & Life Co., Ltd. | 2021-09-08 | 145 | 0 |
| K200521 | Full Automatic(NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2020-06-12 | 102 | 0 |
| K190507 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2019-09-16 | 199 | 0 |
| K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UB | Health & Life Co., Ltd. | 2019-06-13 | 136 | 0 |
| K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | Health & Life Co., Ltd. | 2019-05-20 | 112 | 0 |
| K180240 | Full Automatic(NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2018-10-17 | 261 | 0 |
| K162338 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016-09-21 | 30 | 0 |
| K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016-07-06 | 128 | 0 |
| K161156 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016-06-14 | 50 | 0 |
| K160336 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016-03-29 | 50 | 0 |
| K160145 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016-03-13 | 52 | 0 |
| K153214 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016-01-07 | 63 | 0 |
| K150311 | Full Automatic (NIBP)Blood Pressure Monitor | Health & Life Co., Ltd. | 2015-08-18 | 190 | 0 |
| K142968 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2014-12-19 | 66 | 0 |
| K130564 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | Health & Life Co., Ltd. | 2013-06-19 | 107 | 0 |
| K130563 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | Health & Life Co., Ltd. | 2013-06-18 | 106 | 0 |
| K131121 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | Health & Life Co., Ltd. | 2013-05-29 | 37 | 0 |
| K110074 | HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-M | Health & Life Co., Ltd. | 2012-05-25 | 501 | 0 |
| K113239 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) | Health & Life Co., Ltd. | 2012-03-16 | 135 | 0 |
| K113238 | FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR | Health & Life Co., Ltd. | 2012-03-01 | 120 | 0 |
| K112320 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | Health & Life Co., Ltd. | 2011-09-30 | 50 | 0 |
| K093831 | FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT | Health & Life Co., Ltd. | 2010-03-25 | 101 | 0 |
| K093824 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT | Health & Life Co., Ltd. | 2010-02-16 | 64 | 0 |
| K093823 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, | Health & Life Co., Ltd. | 2010-01-22 | 39 | 0 |
| K092163 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB | Health & Life Co., Ltd. | 2009-11-16 | 123 | 1 |
| K092161 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF | Health & Life Co., Ltd. | 2009-09-30 | 76 | 0 |
| K081738 | ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 | Health & Life Co., Ltd. | 2008-09-17 | 90 | 0 |
| K060835 | HL888SF | Health & Life Co., Ltd. | 2006-04-21 | 25 | 0 |
| K060729 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV | Health & Life Co., Ltd. | 2006-04-12 | 26 | 0 |
| K050711 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT | Health & Life Co., Ltd. | 2005-04-07 | 20 | 0 |
| K050714 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA | Health & Life Co., Ltd. | 2005-04-07 | 20 | 0 |
| K050587 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM | Health & Life Co., Ltd. | 2005-04-05 | 28 | 0 |
| K050169 | HL 200 ELECTRONIC STETHOSCOPE | Health & Life Co., Ltd. | 2005-04-05 | 69 | 0 |
| K050491 | H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS H | Health & Life Co., Ltd. | 2005-03-31 | 34 | 0 |
| K050249 | HL168JP | Health & Life Co., Ltd. | 2005-03-30 | 55 | 0 |
| K043414 | HL 188 & HL 189 BODY FAT METER | Health & Life Co., Ltd. | 2005-02-09 | 58 | 0 |
| K043437 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET | Health & Life Co., Ltd. | 2005-01-12 | 30 | 0 |
| K043186 | H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM | Health & Life Co., Ltd. | 2004-12-06 | 19 | 0 |
| K042853 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA | Health & Life Co., Ltd. | 2004-11-10 | 26 | 0 |
| K042802 | H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS H | Health & Life Co., Ltd. | 2004-10-26 | 18 | 0 |
| K042265 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 | Health & Life Co., Ltd. | 2004-08-31 | 8 | 0 |
| K032837 | HL888BM | Health & Life Co., Ltd. | 2003-10-10 | 29 | 0 |
| K032839 | HL888BA | Health & Life Co., Ltd. | 2003-10-10 | 29 | 0 |
| K033043 | MODIFICATION TO HL168 | Health & Life Co., Ltd. | 2003-10-10 | 11 | 0 |
| K032913 | HL888 AF | Health & Life Co., Ltd. | 2003-10-02 | 30 | 0 |
| K032695 | HL888BF | Health & Life Co., Ltd. | 2003-10-02 | 30 | 0 |
| K031695 | HL168R | Health & Life Co., Ltd. | 2003-07-01 | 29 | 0 |
| K031835 | HL888RA | Health & Life Co., Ltd. | 2003-07-01 | 29 | 0 |
| K030541 | HL888JF | Health & Life Co., Ltd. | 2003-04-24 | 63 | 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