Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vital Signs, Inc. — Predicate Candidate Screening
75 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
230 days90th percentile
75clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112902 | ENFLOW IV FLUID WARMER | Vital Signs, Inc. | 2012-03-14 | 162 | 0 |
| K041309 | IMASK TM | Vital Signs, Inc. | 2004-06-30 | 44 | 0 |
| K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I | Vital Signs, Inc. | 2003-10-15 | 201 | 0 |
| K022402 | DISPOSABLE PRESSURE MANOMETER | Vital Signs, Inc. | 2002-08-22 | 30 | 0 |
| K021315 | SURE-LOK | Vital Signs, Inc. | 2002-08-21 | 118 | 0 |
| K002454 | BREAS HA50 HUMIDIFIER, MODEL HA50 | Vital Signs, Inc. | 2001-03-07 | 209 | 0 |
| K001553 | BREAS PV 100 CPAP SYSTEM | Vital Signs, Inc. | 2000-08-03 | 77 | 0 |
| K000441 | BODYGUARD | Vital Signs, Inc. | 2000-04-11 | 61 | 0 |
| K994044 | CLEEN-ABLE | Vital Signs, Inc. | 2000-02-25 | 88 | 0 |
| K990412 | CUFF-ABLE PLUS | Vital Signs, Inc. | 1999-09-01 | 203 | 0 |
| K984468 | VITAL PEP | Vital Signs, Inc. | 1999-06-01 | 167 | 0 |
| K970196 | T-WALL UNCUFFED TRACHEAL TUBE | Vital Signs, Inc. | 1997-08-21 | 212 | 0 |
| K962438 | MISTY OX TURBOHEATER | Vital Signs, Inc. | 1997-01-13 | 203 | 0 |
| K955417 | VITAL PAK | Vital Signs, Inc. | 1996-03-08 | 102 | 0 |
| K952645 | VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE | Vital Signs, Inc. | 1995-12-13 | 187 | 0 |
| K953120 | VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE | Vital Signs, Inc. | 1995-12-13 | 161 | 0 |
| K951047 | BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, | Vital Signs, Inc. | 1995-06-02 | 88 | 0 |
| K951745 | CONNECTING TUBE | Vital Signs, Inc. | 1995-05-30 | 50 | 0 |
| K950447 | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT | Vital Signs, Inc. | 1995-02-21 | 18 | 0 |
| K945950 | TRIGUARD(TM) SUCTION SYSTEM | Vital Signs, Inc. | 1994-12-27 | 21 | 0 |
| K945455 | GENERAL ANESTHESIA SYSTEM | Vital Signs, Inc. | 1994-12-23 | 46 | 0 |
| K944949 | GENERAL ANESTHESIA SYSTEM | Vital Signs, Inc. | 1994-11-14 | 38 | 1 |
| K935546 | MAC/IV SEDATION KIT | Vital Signs, Inc. | 1994-06-13 | 208 | 0 |
| K934482 | VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600 | Vital Signs, Inc. | 1994-05-02 | 230 | 0 |
| K932347 | COMPACT MASK | Vital Signs, Inc. | 1994-01-10 | 241 | 0 |
| K923865 | 5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID | Vital Signs, Inc. | 1993-02-01 | 182 | 0 |
| K914370 | MECONIUM SUCTION DEVICE (MSD) | Vital Signs, Inc. | 1993-01-06 | 463 | 0 |
| K920885 | VENTILATOR CIRCUITS | Vital Signs, Inc. | 1992-10-23 | 262 | 0 |
| K912577 | BACTERIA FILTER | Vital Signs, Inc. | 1992-04-22 | 315 | 0 |
| K914335 | STRAP, HEAD, GAS MASK | Vital Signs, Inc. | 1992-04-02 | 188 | 0 |
| K914336 | BREATHE EASY | Vital Signs, Inc. | 1992-03-25 | 180 | 0 |
| K905273 | BAUMAN DISPOSABLE LARYNGOSCOPE BLADES | Vital Signs, Inc. | 1992-03-24 | 487 | 0 |
| K915277 | ENDOTRACHEAL CPAP SET | Vital Signs, Inc. | 1992-03-20 | 116 | 0 |
| K914337 | GAS SAMPLING INTERFACES | Vital Signs, Inc. | 1992-03-11 | 166 | 0 |
| K911465 | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL | Vital Signs, Inc. | 1991-10-18 | 198 | 0 |
| K912652 | FLEX-ELBOW | Vital Signs, Inc. | 1991-10-10 | 115 | 0 |
| K912578 | 20CM/H20 PEEP VALVE | Vital Signs, Inc. | 1991-09-11 | 91 | 0 |
| K912650 | 1.1, 1.2, 1.3 TEMPERATURE PROBES | Vital Signs, Inc. | 1991-08-16 | 60 | 0 |
| K912625 | MOUTH TO MASK RESUSCITATOR | Vital Signs, Inc. | 1991-08-02 | 50 | 0 |
| K912626 | BOLUS XENON CIRCUIT | Vital Signs, Inc. | 1991-08-02 | 50 | 0 |
| K912638 | BLOOD PRESSURE CUFFS | Vital Signs, Inc. | 1991-07-25 | 41 | 0 |
| K904899 | VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR | Vital Signs, Inc. | 1991-07-24 | 267 | 0 |
| K905450 | ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE | Vital Signs, Inc. | 1991-07-01 | 208 | 0 |
| K910856 | MANUAL RESUSCITATOR | Vital Signs, Inc. | 1991-06-18 | 110 | 0 |
| K904830 | BACTERIA FILTER | Vital Signs, Inc. | 1991-04-10 | 167 | 0 |
| K904874 | ADJUSTABLE PEEP VALVE | Vital Signs, Inc. | 1991-01-08 | 70 | 0 |
| K901728 | ONE-LUNG CPAP DEVICE | Vital Signs, Inc. | 1990-08-14 | 120 | 0 |
| K882319 | TELEMETRIC STETHOSCOPE | Vital Signs, Inc. | 1988-08-02 | 57 | 0 |
| K861981 | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR | Vital Signs, Inc. | 1986-08-25 | 95 | 0 |
| K862003 | CIRCUIT ANES. BREATHING & COMPONENTS | Vital Signs, Inc. | 1986-07-07 | 41 | 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