Life Design Systems, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Life Design Systems, Inc.” (first 1982, latest 1992), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 52 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) | 7 | 7 |
| BSJ | Mask, Gas, Anesthetic | 3 | 3 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 3 | 3 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 3 | 3 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| BTC | Bag, Reservoir | 1 | 1 |
| BTK | Strap, Head, Gas Mask | 1 | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
Plus 5 more product codes.
Review panels
- Anesthesiology (26)
- General Hospital (2)
- Cardiovascular (1)
Most recent Life Design Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913714 | MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) | BTM | 1992-12-01 | 474 |
| K885313 | HUMIDI-FLEX TM | BYD | 1989-10-11 | 286 |
| K893030 | CHILD SIZE - FILTER FLEX (TM) | CAH | 1989-09-18 | 147 |
| K892862 | FLEX-CUP PERCUSSOR | BYI | 1989-05-25 | 37 |
| K892221 | PULMONARY RESUSCITATOR, MODIFICATION | BTM | 1989-05-18 | 49 |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | BZO | 1989-03-20 | 76 |
| K890108 | MODIFIED CUSHION-FLEX(TM) | BSJ | 1989-01-24 | 21 |
| K884387 | CUSHION FLEX(TM) | BSJ | 1988-11-17 | 30 |
| K884068 | PULMANEX TM (NEO-NATAL SIZE) | BTM | 1988-11-16 | 78 |
| K873179 | HEATER WIRE BREATHING CIRCUIT | BZE | 1988-03-31 | 232 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Life Design Systems, 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. (121 510(k)s)
- Life-Tech Intl., Inc. (68 510(k)s)
- Life Science Instrumentation, Inc. (20 510(k)s)
- Life Support Products, Inc. (20 510(k)s)
- Life-Tech Instruments, Inc. (19 510(k)s)
- Life Shield Healthcare Products, Inc. (17 510(k)s)
- Life-Tech, Inc. (14 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Life Design Systems, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Life Design Systems, Inc.” (first 1982, latest 1992), across 15 product codes in 3 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 Design Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Life Design Systems, Inc. is 52 days.
Which FDA product codes appear under Life Design Systems, Inc.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 7); BSJ (Mask, Gas, Anesthetic, 3); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 3).
Next steps
- See all 29 Life Design Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Life Design Systems, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.