Life Design Systems, Inc.
Mchenry, IL, US
Life Design Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Life Design Systems, Inc. between 1982 and 1992. The busiest year on record is 1986, with 7. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 3 |
| 1984 | 3 |
| 1985 | 3 |
| 1986 | 7 |
| 1987 | 3 |
| 1988 | 3 |
| 1989 | 6 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K913714 | MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) | BTM | Substantially Equivalent | |
| K885313 | HUMIDI-FLEX TM | BYD | Substantially Equivalent | |
| K893030 | CHILD SIZE - FILTER FLEX (TM) | CAH | Substantially Equivalent | |
| K892862 | FLEX-CUP PERCUSSOR | BYI | Substantially Equivalent | |
| K892221 | PULMONARY RESUSCITATOR, MODIFICATION | BTM | Substantially Equivalent | |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | BZO | Substantially Equivalent | |
| K890108 | MODIFIED CUSHION-FLEX(TM) | BSJ | Substantially Equivalent | |
| K884387 | CUSHION FLEX(TM) | BSJ | Substantially Equivalent | |
| K884068 | PULMANEX TM (NEO-NATAL SIZE) | BTM | Substantially Equivalent | |
| K873179 | HEATER WIRE BREATHING CIRCUIT | BZE | Substantially Equivalent | |
| K863857 | PULSE-OX | DQA | Substantially Equivalent | |
| K864681 | CARHILL ONE-WAY RESUSCITATION VALVE | CBP | Substantially Equivalent | |
| K871669 | BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE | CAI | Substantially Equivalent | |
| K862448 | FLOW GENERATOR FOR SLEEP APNEA, LDS 1500 | BZD | Substantially Equivalent | |
| K863026 | PULMANEX TM (MODIFICATION) | BTM | Substantially Equivalent | |
| K861758 | CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA | BYE | Substantially Equivalent | |
| K860659 | END TIDAL CO2 SAMPLING CIRCUIT | BZO | Substantially Equivalent | |
| K860693 | PULMANEX (TM) | BTM | Substantially Equivalent | |
| K854822 | LDS PEEP VALVE | BYE | Substantially Equivalent | |
| K854458 | CUSHION-FLEX TM-CPAP FACE MASK | BYE | Substantially Equivalent | |
| K854537 | HEADSTRAP | BTK | Substantially Equivalent | |
| K854037 | PULMANEX | BTM | Substantially Equivalent | |
| K844729 | RESUSCITATOR, PULMONARY, MANUAL | BTM | Substantially Equivalent | |
| K843169 | CUSHION-FLEX TM | BSJ | Substantially Equivalent | |
| K841264 | BABYSET TM & PAC TM -PULMONARY ASSIST | CAI | Substantially Equivalent | |
| K841236 | FILTER-FLEX | CAH | Substantially Equivalent | |
| K822116 | ANESTHESIA BREATHING BAG, VARIOUS SIZES | BTC | Substantially Equivalent | |
| K821846 | LDS MONITORING ELECTRODE | DRX | Substantially Equivalent | |
| K821087 | ANESTHESIA BREATHING CIRCUIT | CAI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTCBag, Reservoir
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BYDCondenser, Heat And Moisture (Artificial Nose)
- DRXElectrode, Electrocardiograph
- CAHFilter, Bacterial, Breathing-Circuit
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BSJMask, Gas, Anesthetic
- DQAOximeter
- BYIPercussor, Powered-Electric
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BTKStrap, Head, Gas Mask
- CBPValve, Non-Rebreathing
- BTMVentilator, Emergency, Manual (Resuscitator)
- BZDVentilator, Non-Continuous (Respirator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain