Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DRS — Predicate Candidate Screening

148 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time

259 days90th percentile

148clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K242909	FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; Volu	Edwards Lifesciences, LLC	2025-03-21	178	0
K221782	Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Do	Merit Medical Pte. , Ltd.	2023-03-17	269	0
K172458	HemoDraw Plus Closed Blood Sampling System with LogiCal Tran	Smiths Medical Asd, Inc.	2017-11-09	87	0
K163172	HemoDraw Plus Closed Blood Sampling System with LogiCal Tran	Smiths Medical Asd, Inc.	2017-05-24	191	0
K161408	Compass Cast and MAP	Centurion Medical Products Corporation	2016-11-22	186	0
K152472	Disposable Pressure Transducer	Zhejiang Haisheng Medical Device Co., Ltd.	2016-10-31	427	0
K152980	Flo Trac sensor, Volume View sensor	Edwards Lifesciences, LLC	2016-01-19	102	4
K151040	Art-line Single channel blood pressure system, Art-line Doub	Biometrix , Ltd.	2015-09-04	137	0
K133624	COMPASS CT, COMPASS CT PORT	Mirador Biomedical	2014-04-18	143	0
K123095	MEDLINE BLOOD PRESSURE TRANSDUCER	Medline Industries, Inc.	2013-05-08	218	0
K120624	ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)	Elcam Medical Acal	2012-06-08	99	0
K112203	COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS	Mirador Biomedical, Inc.	2011-12-14	135	0
K102033	COMBITRANS MONITORING SETS AND ACCESSORIES	B.Braun Melsungen AG	2011-04-07	262	0
K103715	COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / IN	Mirador Biomedical, Inc.	2011-01-20	30	0
K101189	REAVILLMED PRESSURE MONITORING SYSTEM AND PICC	Reavillmed	2010-12-22	238	0
K101518	COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE	Mirador Biomedical, Inc.	2010-10-13	133	0
K092644	TERUMO PRESSURE ISOLATOR	Terumo Cardiovascular Systems Corp.	2009-12-10	105	0
K091408	DISPOSABLE PRESSURE TRANSDUCER	Shenzhen Ant Hi-Tech Industrial Co., Ltd.	2009-08-18	98	0
K070710	ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM	Biosensors International-USA	2007-04-19	36	0
K062342	TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT	Sentra Medical Devices, LLC	2006-09-25	45	0
K061573	TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT	Hospira, Inc.	2006-09-19	104	193
K052828	DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)	Hospira, Inc.	2006-02-17	135	0
K043065	VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, M	Edwards Lifesciences, LLC	2005-01-26	82	1
K983372	BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP	Sunscope Intl., Inc.	1999-02-05	134	0
K981747	BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX	Sunscope Intl., Inc.	1998-08-20	94	0
K981745	BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX	Sunscope Intl., Inc.	1998-07-17	60	0
K961404	MX960 REUSABLE PRESSURE TRANSDUCER	Medex, Inc.	1996-06-27	77	5
K951722	PERCEPTOR COMPENSATOR MORSE MANIFOLD	Namic	1996-03-25	346	0
K951129	NOVATRANS II	Medex, Inc.	1995-04-05	23	0
K930888	WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM	Ralin Medical, Inc.	1993-07-21	152	0
K921343	COBE PATIENT MONITORING PRODUCTS	Cobe Cardiovascular, Inc.	1993-01-05	292	0
K920977	MERITRANS(TM) DISPOSABLE TRANSDUCER	Merit Medical Systems, Inc.	1992-12-11	284	0
K921898	TAD MODEL #9655	Loric Technology	1992-11-02	194	0
K910764	THE PERCEPTOR(TM) STAND ALONE TRANSDUCER	North American Instrument Corp.	1991-04-22	81	1
K904777	SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS	Baxter Healthcare Corp	1991-01-15	85	0
K904601	ADVANCE DISPOSABLE PRESSURE TRANSDUCER	Advance Medical Designs, Inc.	1990-12-17	68	0
K902472	MORSE DT MANIFOLD	North American Instrument Corp.	1990-08-23	80	2
K902453	OSCILLOMETRIC PULSE DETECTION DEVICE	Thomas J. Fogarty, M.D.	1990-08-23	83	0
K900551	MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.	Matrix Medica, Inc.	1990-05-09	92	0
K884235	COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT	Burron Medical, Inc.	1990-03-06	515	0
K885296	MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F	Baxter Healthcare Corp	1989-01-25	29	0
K884919	DISPOSABLE DOME STOCK #D-300	Advanced Medical, Inc.	1989-01-05	38	0
K881297	BARO-GRAF 24	Instromedix, Inc.	1988-09-16	172	0
K883095	MX860, REUSABLE PRESSURE TRANSDUCER	Medex, Inc.	1988-09-12	52	0
K882118	MODEL 700 PATIENT MONITOR	Ivy Biomedical Systems, Inc.	1988-08-02	75	0
K873168	SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS	Spectramed, Inc.	1988-01-12	154	0
K872596	TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30	American Edwards Laboratories	1987-09-30	90	0
K870356	TATCH-IT	Reunion Medical Co.	1987-06-12	134	0
K871371	DIGITAL SPHYGMOMANOMETER	Omron Tateisi Electronics Co.	1987-06-12	66	0
K870301	MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER	Medex, Inc.	1987-05-06	98	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