Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAP — Predicate Candidate Screening
78 FDA 510(k) clearances under this product code; the 50 most recent screened below.
66 daysmedian FDA review time
276 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201666 | SINGLE USE MANOMETER | Flexicare Medical Limited. | 2020-11-13 | 147 | 0 |
| K182292 | VORTRAN APM-Plus | Vortran Medical Technology 1, Inc. | 2019-09-18 | 391 | 0 |
| K180510 | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. | 2019-05-01 | 428 | 0 |
| K172284 | NAPA LP-15 Airway Pressure Monitor | Drw Medical, LLC | 2018-02-09 | 196 | 0 |
| K153733 | VORTRAN Manometer | Vortran Medical Technology 1, Inc. | 2016-09-16 | 263 | 0 |
| K143148 | Disposable Pressure Manometer (DPM) | Westmed, Inc. | 2015-08-11 | 281 | 0 |
| K140370 | DISPOSABLE PRESSURE MANOMETER | Besmed Health Business Corp | 2014-06-19 | 125 | 0 |
| K122627 | GIO DIGITAL PRESSURE GUAGES | Galemed Corp. | 2013-08-22 | 359 | 0 |
| K122077 | MANOMETER | Intersurgical, Inc. | 2013-01-10 | 178 | 0 |
| K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | Ventlab Corp. | 2012-05-24 | 128 | 0 |
| K103639 | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY | Vortran Medical Technology 1, Inc. | 2011-09-15 | 276 | 0 |
| K110119 | PRESSURE MANOMETER | Neoforce Group, Inc. | 2011-06-10 | 143 | 0 |
| K102377 | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOS | A Plus Medical | 2010-11-18 | 90 | 0 |
| K081778 | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | Instrumentation Industries, Inc. | 2008-09-12 | 81 | 0 |
| K050309 | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 | Viasys Medsystems | 2005-03-25 | 45 | 0 |
| K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | Ambu, Inc. | 2004-07-22 | 97 | 0 |
| K022402 | DISPOSABLE PRESSURE MANOMETER | Vital Signs, Inc. | 2002-08-22 | 30 | 0 |
| K003497 | DISPOSABLE PRESSURE MONITOR | Engineered Medical Systems | 2000-11-30 | 17 | 0 |
| K000959 | CRITERION 60 OR PM 60 | Caradyne, Ltd. | 2000-06-22 | 90 | 0 |
| K992101 | CRITERION 40 OR PM 40 | Caradyne, Ltd. | 2000-01-06 | 198 | 0 |
| K973347 | TSX PRM PULMONARY RESUSCITATION MONITOR | Spiracle Technology | 1998-07-23 | 321 | 0 |
| K961318 | 1ST RESPONSE DISPOSABLE MANOMETER | Intertech Resources, Inc. | 1996-12-17 | 256 | 0 |
| K954486 | MERCURY AIRWAY PRESSURE MANOMETER | Mercury Medical | 1996-04-25 | 211 | 0 |
| K936009 | AMS 3000M | Acutronic Medical Systems AG | 1995-05-03 | 503 | 0 |
| K943146 | PORTA-RESP MONITOR | S & M Instrument Co. | 1994-11-28 | 151 | 0 |
| K940375 | MICRO MPM | Micro Direct, Inc. | 1994-11-21 | 299 | 0 |
| K931394 | CM5000R REMOTE INDICATOR | Canadian Monaghan , Ltd. | 1993-07-01 | 104 | 0 |
| K931287 | CM7000 REMOTE INDICATOR | Canadian Monaghan , Ltd. | 1993-07-01 | 111 | 0 |
| K925673 | AIRWAY PRESSURE MONITOR CM 5000 NGAN | Canadian Monaghan , Ltd. | 1993-06-09 | 211 | 0 |
| K921978 | BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE | Core-M, Inc. | 1992-11-17 | 203 | 0 |
| K904935 | RESPIRONICS' DIGITAL MANOMETER | Respironics, Inc. | 1991-04-03 | 153 | 0 |
| K902276 | RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.) | Respironics, Inc. | 1990-08-17 | 88 | 0 |
| K902381 | PENLON BREATHING SYSTEM PRESSURE MONITOR | Penlon, Inc. | 1990-08-17 | 79 | 0 |
| K896136 | INFANT C.P.A.P. MONITOR | Hudson Oxygen Therapy Sales Co. | 1990-01-09 | 78 | 0 |
| K895747 | VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR | Hudson Oxygen Therapy Sales Co. | 1989-10-27 | 31 | 0 |
| K894361 | LIFECARE PRESSURE ALARM CAT. NO. 34-010 | Lifecare Services, Inc. | 1989-10-05 | 83 | 0 |
| K894689 | PENLON IDP PRESSURE FAILURE ALARM | Penlon, Inc. | 1989-08-10 | 17 | 0 |
| K892942 | BREATH TRACKER | Core-M, Inc. | 1989-06-23 | 63 | 0 |
| K890010 | CM 7000MR | Trudell Medical | 1989-06-12 | 160 | 0 |
| K873953 | CM 5000R REMOTE AIRWAY PRESSURE | Canadian Monaghan , Ltd. | 1987-10-27 | 29 | 0 |
| K871336 | M-1 PRESSURE MONITOR | Bio-Med Devices, Inc. | 1987-06-05 | 63 | 0 |
| K871139 | M-10 VENTILATION MONITOR | Bio-Med Devices, Inc. | 1987-04-21 | 29 | 0 |
| K871083 | CM 5000 MONITOR AIRWAY PRESSURE | Canadian Monaghan , Ltd. | 1987-04-08 | 21 | 0 |
| K864536 | OHMEDA 5500 AIRWAY PRESSURE MONITOR | Ohmeda Medical | 1987-01-12 | 56 | 0 |
| K861720 | MODIFIED BAROMED BREATHING PRESSURE MONITOR | Draeger Medical, Inc. | 1986-05-09 | 4 | 0 |
| K861330 | SECHRIST AIRWAY PRESSURE MONITOR MODEL 600 | Sechrist Industries, Inc. | 1986-04-11 | 2 | 0 |
| K854934 | VENTILATOR PRESSURE ALARM MODEL VPA-100 | Respiratory Support Products, Inc. | 1985-12-24 | 14 | 0 |
| K852826 | AN PRESSURE MONITOR | Ferguson Medical | 1985-12-03 | 154 | 0 |
| K852824 | PMA PRESSURE MONITOR | Ferguson Medical | 1985-12-03 | 155 | 0 |
| K851905 | LPA-2 REMOTE ALARM | Life Products, Inc. | 1985-07-08 | 69 | 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