A Plus Medical: FDA clearances and approvals
A Plus Medical has 7 FDA 510(k) clearances (first 2009, latest 2012), across 5 product codes in 1 review panel. Median 510(k) review time: 100 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 87 |
| 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 3 | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| NHK | Resuscitator, Manual, Non Self-Inflating | 1 | 1 |
Review panels
- Anesthesiology (7)
Most recent A Plus Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112852 | BABI PLUS NEONATAL RESUSCITATION BAG | BTM | 2012-01-13 | 87 |
| K110471 | BABI PLUS INFANT NASAL CANNULA SYSTEM | BZD | 2011-10-07 | 231 |
| K110383 | BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 | BZD | 2011-08-01 | 172 |
| K102377 | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 | CAP | 2010-11-18 | 90 |
| K093716 | BABI PLUS INFANT NASAL CANNULA SYSTEM | BZD | 2010-05-13 | 162 |
| K092687 | VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER | NHK | 2009-11-23 | 83 |
| K090317 | BABI*PLUS BUBBLE PAP VALVE | BYE | 2009-05-20 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named A Plus Medical.
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.
Frequently asked questions
How many FDA 510(k) clearances does A Plus Medical have?
A Plus Medical has 7 FDA 510(k) clearances (first 2009, latest 2012), across 5 product codes in 1 review panel.
How long does FDA take to clear A Plus Medical's 510(k)s?
The median time from FDA receipt to decision across A Plus Medical's cleared 510(k)s is 100 days.
What devices does A Plus Medical make?
Its most frequent FDA product codes are BZD (Ventilator, Non-Continuous (Respirator), 3); BTM (Ventilator, Emergency, Manual (Resuscitator), 1); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 1).
Has A Plus Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching A Plus Medical. Related entities may recall under other names.
Next steps
- See all 7 A Plus Medical clearances with predicates and recalls
- Run predicate analysis for product code BZD, A Plus Medical'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.