Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZH — Predicate Candidate Screening
81 FDA 510(k) clearances under this product code; the 50 most recent screened below.
184 daysmedian FDA review time
412 days90th percentile
81clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | 2026-06-23 | 270 | 0 |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 | 268 | 0 |
| K241338 | Peak Flow Meter | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 | 232 | 0 |
| K232588 | Aluna 2 | Knox Medical Diagnostics | 2024-11-25 | 458 | 0 |
| K230423 | Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co., Ltd. | 2024-02-23 | 371 | 0 |
| K222810 | TD-7301 Peak Flow meter | Gostar Co., Ltd. | 2023-12-19 | 459 | 0 |
| K203196 | Peak flow meter | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021-05-26 | 210 | 0 |
| K200832 | Safey Peak Flow Meter | Safey Medical Devices Pvt, Ltd. | 2020-07-30 | 122 | 0 |
| K193311 | Aluna | Knox Medical Diagnostics, Inc. | 2020-03-25 | 117 | 0 |
| K191239 | Smart Peak Flow Meter | Guangzhou Homesun Medical Technology Co., Ltd. | 2019-12-06 | 212 | 0 |
| K180487 | Peak.me | Breathe Me, Ltd. | 2018-10-26 | 245 | 0 |
| K181666 | Smart One | Mir Medical International Research | 2018-08-01 | 37 | 0 |
| K172804 | Besmed Peak Flow Meter | Besmed Health Business Corp | 2018-01-11 | 115 | 0 |
| K170281 | MSA100BT Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | 2017-10-06 | 249 | 0 |
| K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | 2016-06-03 | 296 | 0 |
| K133975 | MSA100 PEAK FLOW METER | Beijing M&B Electronic Instruments Co., Ltd. | 2014-10-03 | 281 | 0 |
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | Monaghan Medical Corp. | 2013-04-17 | 117 | 0 |
| K101380 | RXPEAKFLOW | Noble Marketing | 2010-09-13 | 119 | 0 |
| K092335 | PEAK EXPIRATORY FLOW METER, KN-9710 | K-Jump Health Co., Ltd. | 2010-04-09 | 248 | 0 |
| K091412 | CLEAN PEAK FLOW METER | Viasys Healthcare GmbH | 2009-08-21 | 100 | 0 |
| K082899 | DYNAMIPEAK PEAK FLOW METER | Dynamitech Medical, Inc. | 2009-03-10 | 161 | 0 |
| K053156 | MINI-WRIGHT DIGITAL, MODEL 3120001 | Clement Clarke Intl., Ltd. | 2006-01-31 | 78 | 0 |
| K050853 | PMP4 SPIROPRO | Card Guard Scientific Survival , Ltd. | 2005-05-04 | 30 | 0 |
| K040723 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, M | Microlife Intellectual Property GmbH | 2004-06-10 | 80 | 0 |
| K031024 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 | Microlife Corp. | 2003-11-14 | 228 | 0 |
| K030586 | MICROPEAK | Micro Direct, Inc. | 2003-08-27 | 184 | 0 |
| K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 2003-05-23 | 9 | 0 |
| K022124 | GALEMED PEAK FLOW METER, MODELS 3751/3752 | Galemed Corp. | 2003-04-03 | 276 | 0 |
| K023097 | TRUEZONE PEAK FLOW METER | Monaghan Medical Corp. | 2003-03-07 | 170 | 0 |
| K013489 | KP + LFM | Pds Healthcare Products, Inc. | 2001-11-29 | 38 | 0 |
| K010009 | KOKO PEAK KP; KOKO PEAK KP+ | Pds Healthcare Products, Inc. | 2001-06-01 | 150 | 0 |
| K980951 | ONEFLOW | Sti Medical | 2000-02-25 | 714 | 0 |
| K991412 | VITALOGRAPH MICRO | Vitalograph, Inc. | 2000-02-04 | 287 | 0 |
| K992618 | RESPALERT | Harwill Medical (Pty) , Ltd. | 1999-10-29 | 86 | 0 |
| K991212 | MODIFICATION TO TRUZONE PEAK FLOW METER | Monaghan Medical Corp. | 1999-07-01 | 83 | 0 |
| K982334 | AIRZONE PEAK FLOWMETER | Clement Clarke Intl., Ltd. | 1999-01-14 | 196 | 0 |
| K982995 | ACCUTRAX, MODEL EPF840 | Korr Medical Technologies, Inc. | 1998-12-04 | 99 | 0 |
| K982676 | AIRWATCH II ZONE | Enact Health Management Systems | 1998-10-29 | 90 | 0 |
| K982675 | AIRWATCH II ZONELESS | Enact Health Management Systems | 1998-10-29 | 90 | 0 |
| K980550 | WHISTLE WATCH | Harwill Medical (Pty) , Ltd. | 1998-08-27 | 196 | 0 |
| K980960 | IN-CHECK INSPIRATORY FLOWMETER | Clement Clarke Intl., Ltd. | 1998-06-10 | 86 | 0 |
| K980443 | PEAK FLOW METER MINIMAX | The D&T, Inc. | 1998-04-30 | 84 | 0 |
| K970507 | PEAK FLOW METER | Intl. Medical, Inc. | 1997-06-13 | 123 | 0 |
| K961779 | MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER | Avion Medical Products, Inc. | 1997-06-13 | 401 | 0 |
| K964130 | AEROGEAR ASTHMA ACTION KIT | Monaghan Medical Corp. | 1997-01-10 | 87 | 0 |
| K962074 | VM PLUS PEAK FLOWMETER | Clement Clarke Intl., Ltd. | 1997-01-02 | 219 | 0 |
| K963089 | TRUZONE PEAK FLOW METER | Monaghan Medical Corp. | 1996-11-06 | 90 | 0 |
| K963095 | TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 1996-11-04 | 88 | 0 |
| K962924 | PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM | Healthscan Products, Inc. | 1996-10-25 | 88 | 0 |
| K962929 | PERSONAL BEST II | Healthscan Products, Inc. | 1996-10-24 | 87 | 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