Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Life Design Systems, Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
286 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913714 | MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) | Life Design Systems, Inc. | 1992-12-01 | 474 | 0 |
| K885313 | HUMIDI-FLEX TM | Life Design Systems, Inc. | 1989-10-11 | 286 | 0 |
| K893030 | CHILD SIZE - FILTER FLEX (TM) | Life Design Systems, Inc. | 1989-09-18 | 147 | 0 |
| K892862 | FLEX-CUP PERCUSSOR | Life Design Systems, Inc. | 1989-05-25 | 37 | 0 |
| K892221 | PULMONARY RESUSCITATOR, MODIFICATION | Life Design Systems, Inc. | 1989-05-18 | 49 | 0 |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | Life Design Systems, Inc. | 1989-03-20 | 76 | 0 |
| K890108 | MODIFIED CUSHION-FLEX(TM) | Life Design Systems, Inc. | 1989-01-24 | 21 | 0 |
| K884387 | CUSHION FLEX(TM) | Life Design Systems, Inc. | 1988-11-17 | 30 | 0 |
| K884068 | PULMANEX TM (NEO-NATAL SIZE) | Life Design Systems, Inc. | 1988-11-16 | 78 | 0 |
| K873179 | HEATER WIRE BREATHING CIRCUIT | Life Design Systems, Inc. | 1988-03-31 | 232 | 0 |
| K863857 | PULSE-OX | Life Design Systems, Inc. | 1987-10-07 | 370 | 0 |
| K864681 | CARHILL ONE-WAY RESUSCITATION VALVE | Life Design Systems, Inc. | 1987-05-21 | 170 | 0 |
| K871669 | BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE | Life Design Systems, Inc. | 1987-05-19 | 21 | 0 |
| K862448 | FLOW GENERATOR FOR SLEEP APNEA, LDS 1500 | Life Design Systems, Inc. | 1986-11-14 | 140 | 0 |
| K863026 | PULMANEX TM (MODIFICATION) | Life Design Systems, Inc. | 1986-08-26 | 15 | 0 |
| K861758 | CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA | Life Design Systems, Inc. | 1986-07-14 | 69 | 0 |
| K860659 | END TIDAL CO2 SAMPLING CIRCUIT | Life Design Systems, Inc. | 1986-04-17 | 52 | 0 |
| K860693 | PULMANEX (TM) | Life Design Systems, Inc. | 1986-03-27 | 30 | 0 |
| K854822 | LDS PEEP VALVE | Life Design Systems, Inc. | 1986-02-24 | 83 | 1 |
| K854458 | CUSHION-FLEX TM-CPAP FACE MASK | Life Design Systems, Inc. | 1986-01-15 | 70 | 0 |
| K854537 | HEADSTRAP | Life Design Systems, Inc. | 1985-12-03 | 20 | 0 |
| K854037 | PULMANEX | Life Design Systems, Inc. | 1985-11-01 | 51 | 0 |
| K844729 | RESUSCITATOR, PULMONARY, MANUAL | Life Design Systems, Inc. | 1985-03-25 | 111 | 0 |
| K843169 | CUSHION-FLEX TM | Life Design Systems, Inc. | 1984-08-20 | 7 | 0 |
| K841264 | BABYSET TM & PAC TM -PULMONARY ASSIST | Life Design Systems, Inc. | 1984-06-15 | 81 | 0 |
| K841236 | FILTER-FLEX | Life Design Systems, Inc. | 1984-04-05 | 14 | 0 |
| K822116 | ANESTHESIA BREATHING BAG, VARIOUS SIZES | Life Design Systems, Inc. | 1982-08-16 | 28 | 0 |
| K821846 | LDS MONITORING ELECTRODE | Life Design Systems, Inc. | 1982-07-30 | 38 | 0 |
| K821087 | ANESTHESIA BREATHING CIRCUIT | Life Design Systems, Inc. | 1982-05-14 | 25 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda