Vital Signs, Inc.: FDA clearances and approvals
Vital Signs, Inc. has 75 FDA 510(k) clearances (first 1979, latest 2012), across 37 product codes in 5 review panels. Median 510(k) review time: 88 days. openFDA lists 2 product recalls by a recalling firm named Vital Signs, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 162 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 6 | 6 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 6 | 6 |
| CAH | Filter, Bacterial, Breathing-Circuit | 5 | 5 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 5 | 5 |
| BTR | Tube, Tracheal (W/Wo Connector) | 4 | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 4 | 4 |
| BSJ | Mask, Gas, Anesthetic | 3 | 3 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 3 | 3 |
| DXQ | Blood Pressure Cuff | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
Plus 27 more product codes.
Review panels
- Anesthesiology (52)
- General Hospital (14)
- Cardiovascular (6)
- Radiology (2)
- Obstetrics and Gynecology (1)
Most recent Vital Signs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112902 | ENFLOW IV FLUID WARMER | LGZ | 2012-03-14 | 162 |
| K041309 | IMASK TM | BZD | 2004-06-30 | 44 |
| K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I | BZD | 2003-10-15 | 201 |
| K022402 | DISPOSABLE PRESSURE MANOMETER | CAP | 2002-08-22 | 30 |
| K021315 | SURE-LOK | FMI | 2002-08-21 | 118 |
| K002454 | BREAS HA50 HUMIDIFIER, MODEL HA50 | BTT | 2001-03-07 | 209 |
| K001553 | BREAS PV 100 CPAP SYSTEM | BZD | 2000-08-03 | 77 |
| K000441 | BODYGUARD | FMI | 2000-04-11 | 61 |
| K994044 | CLEEN-ABLE | DXQ | 2000-02-25 | 88 |
| K990412 | CUFF-ABLE PLUS | DXQ | 1999-09-01 | 203 |
65 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-07-15.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Vital Signs, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Vital Signs, Inc. have?
Vital Signs, Inc. has 75 FDA 510(k) clearances (first 1979, latest 2012), across 37 product codes in 5 review panels.
How long does FDA take to clear Vital Signs, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vital Signs, Inc.'s cleared 510(k)s is 88 days.
What devices does Vital Signs, Inc. make?
Its most frequent FDA product codes are BTM (Ventilator, Emergency, Manual (Resuscitator), 6); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 6); CAH (Filter, Bacterial, Breathing-Circuit, 5).
Has Vital Signs, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Vital Signs, Inc; the most recent began 2010-07-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 75 Vital Signs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Vital Signs, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.