Lifeguard Medical Products, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Lifeguard Medical Products, Inc.” (first 1981, latest 2002), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| CAN | Regulator, Pressure, Gas Cylinder | 2 | 2 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Review panels
Most recent Lifeguard Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013421 | LIFEGUARD NASAL CPAP MASK AND ACCESSORIES | BZD | 2002-01-08 | 84 |
| K915296 | MONOPOLAR ELECTRODE | GEI | 1992-09-03 | 293 |
| K920471 | LEVY ARTICULATING RETRACTOR | GAD | 1992-06-23 | 147 |
| K915505 | REGULATOR FLOWMETER | CAN | 1992-04-22 | 135 |
| K915297 | TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM | HET | 1992-02-11 | 88 |
| K915298 | SUCTION/IRRIGATION CANNULA; CATLOG #532.00 | GCJ | 1992-01-23 | 69 |
| K880958 | LIFEGUARD BACTERIAL AND VIRAL FILTER | CAH | 1988-04-27 | 51 |
| K881087 | LIFEGUARD SINGLE USE MANUAL RESUSCITATORS | BTM | 1988-04-14 | 31 |
| K881086 | LIFEGUARD MOUTH TO MASK RESUSCITATOR | BTM | 1988-04-14 | 31 |
| K880959 | LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY | BZO | 1988-04-14 | 38 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lifeguard Medical 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lifeguard Medical Products, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Lifeguard Medical Products, Inc.” (first 1981, latest 2002), across 10 product codes in 4 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 Lifeguard Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lifeguard Medical Products, Inc. is 76 days.
Which FDA product codes appear under Lifeguard Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 2); CAN (Regulator, Pressure, Gas Cylinder, 2); BYJ (Unit, Liquid-Oxygen, Portable, 1).
Next steps
- See all 12 Lifeguard Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Lifeguard Medical 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.