Life Shield Healthcare Products, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Life Shield Healthcare Products, Inc.” (first 1993, latest 1993), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 10 | 10 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| BTC | Bag, Reservoir | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Review panels
- Anesthesiology (16)
- General Hospital (1)
Most recent Life Shield Healthcare Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932562 | GAS SAMPLING LINES AND CONNECTORS | CAI | 1993-07-23 | 57 |
| K932561 | GUEDEL AIRWAYS | BTR | 1993-07-22 | 56 |
| K932560 | VOLUME VENTILATORS | BZO | 1993-07-22 | 56 |
| K932558 | ADULT ANESTHESIA BREATHING CIRCUIT | CAI | 1993-07-22 | 56 |
| K932557 | HYPERINFLATION SYSTEM | BZR | 1993-07-22 | 56 |
| K932563 | VENTILATOR HOSES | BZO | 1993-07-16 | 50 |
| K932559 | MAPLESON D CIRCUITS | CAI | 1993-07-16 | 50 |
| K932197 | CUSTOM ANESTHESIA CIRCUITS | CAI | 1993-07-02 | 57 |
| K932196 | COAXIAL CIRCUITS | CAI | 1993-07-02 | 57 |
| K932195 | ADULT GAS SAMPLING CIRCUITS | CAI | 1993-07-02 | 57 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Life Shield Healthcare Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Life Spine, Inc. (123 510(k)s)
- Life Design Systems, Inc. (29 510(k)s)
- Life Science Instrumentation, Inc. (20 510(k)s)
- Life Support Products, Inc. (20 510(k)s)
- Life Sciences Manufacturing, Inc. (12 510(k)s)
- Life Technologies Corporation (10 510(k)s)
- Life Products, Inc. (10 510(k)s)
- Life Corp. (5 510(k)s)
- Life Sensing Instrument Company, Inc. (5 510(k)s)
- Life Enhancement Technologies, LLC (3 510(k)s)
- Life Global Group, LLC (3 510(k)s)
- Life Medical Sciences, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Life Shield Healthcare Products, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Life Shield Healthcare Products, Inc.” (first 1993, latest 1993), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Life Shield Healthcare Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Life Shield Healthcare Products, Inc. is 57 days.
Which FDA product codes appear under Life Shield Healthcare Products, Inc.?
The most frequent FDA product codes under this applicant name are CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 10); BZO (Set, Tubing And Support, Ventilator (W Harness), 2); BTC (Bag, Reservoir, 1).
Next steps
- See all 17 Life Shield Healthcare Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAI, Life Shield Healthcare Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.